Patient Selectable Knee Joint Arthroplasty Devices

ABSTRACT

Disclosed herein are methods and devices for repairing articular surfaces in a knee joint. The articular surface repairs are customizable or highly selectable for each patient and geared toward providing optimal fit and function. Kits are also provided to enable customized repairs to be performed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 10/997,407, filedNov. 24, 2004, entitled “PATIENT SELECTABLE KNEE JOINT ARTHROPLASTYDEVICES,” which is a continuation-in-part of U.S. Ser. No. 10/752,438,filed Jan. 5, 2004, entitled “PATIENT SELECTABLE KNEE ARTHROPLASTYDEVICES,” which is a continuation-in-part of U.S. application Ser. No.10/724,010 filed Nov. 25, 2003 entitled “PATIENT SELECTABLE JOINTARTHROPLASTY DEVICES AND SURGICAL TOOLS FACILITATING INCREASED ACCURACY,SPEED AND SIMPLICITY IN PERFORMING TOTAL AND PARTIAL JOINTARTHROPLASTY,” which is a continuation-in-part of U.S. Ser. No.10/305,652 entitled “METHODS AND COMPOSITIONS FOR ARTICULAR REPAIR,”filed Nov. 27, 2002, which is a continuation-in-part of U.S. Ser. No.10/160,667, filed May 28, 2002, which in turn claims the benefit of U.S.Ser. No. 60/293,488 entitled “METHODS TO IMPROVE CARTILAGE REPAIRSYSTEMS”, filed May 25, 2001, U.S. Ser. No. 60/363,527, entitled “NOVELDEVICES FOR CARTILAGE REPAIR, filed Mar. 12, 2002 and U.S. Ser. Nos.60/380,695 and 60/380,692, entitled “METHODS AND COMPOSITIONS FORCARTILAGE REPAIR,” and “METHODS FOR JOINT REPAIR,” filed May 14, 2002,all of which applications are hereby incorporated by reference in theirentireties.

U.S. Ser. No. 10/997,407 is also a continuation-in-part of U.S.application Ser. No. 10/681,750 filed Oct. 7, 2003 entitled “MINIMALLYINVASIVE JOINT IMPLANT WITH 3-DIMENSIONAL GEOMETRY MATCHING THEARTICULAR SURFACES.”

This application claims benefit of U.S. provisional patent application60/467,686 filed May 2, 2003 entitled “JOINT IMPLANTS.”

FIELD OF THE INVENTION

The present invention relates to orthopedic methods, systems and devicesand more particularly relates to methods, systems and devices forarticular resurfacing in the knee.

BACKGROUND OF THE INVENTION

There are various types of cartilage, e.g., hyaline cartilage andfibrocartilage. Hyaline cartilage is found at the articular surfaces ofbones, e.g., in the joints, and is responsible for providing the smoothgliding motion characteristic of moveable joints. Articular cartilage isfirmly attached to the underlying bones and measures typically less than5 mm in thickness in human joints, with considerable variation dependingon the joint and the site within the joint.

Adult cartilage has a limited ability of repair; thus, damage tocartilage produced by disease, such as rheumatoid and/or osteoarthritis,or trauma can lead to serious physical deformity and debilitation.Furthermore, as human articular cartilage ages, its tensile propertieschange. The superficial zone of the knee articular cartilage exhibits anincrease in tensile strength up to the third decade of life, after whichit decreases markedly with age as detectable damage to type II collagenoccurs at the articular surface. The deep zone cartilage also exhibits aprogressive decrease in tensile strength with increasing age, althoughcollagen content does not appear to decrease. These observationsindicate that there are changes in mechanical and, hence, structuralorganization of cartilage with aging that, if sufficiently developed,can predispose cartilage to traumatic damage.

Once damage occurs, joint repair can be addressed through a number ofapproaches. One approach includes the use of matrices, tissue scaffoldsor other carriers implanted with cells (e.g., chondrocytes, chondrocyteprogenitors, stromal cells, mesenchymal stem cells, etc.). Thesesolutions have been described as a potential treatment for cartilage andmeniscal repair or replacement. See, also, International Publications WO99/51719 to Fofonoff, published Oct. 14, 1999; WO01/91672 to Simon etal., published Dec. 6, 2001; and WO01/17463 to Mannsmann, published Mar.15, 2001; U.S. Pat. No. 6,283,980 B1 to Vibe-Hansen et al., issued Sep.4, 2001, U.S. Pat. No. 5,842,477 to Naughton issued Dec. 1, 1998, U.S.Pat. No. 5,769,899 to Schwartz et al. issued Jun. 23, 1998, U.S. Pat.No. 4,609,551 to Caplan et al. issued Sep. 2, 1986, U.S. Pat. No.5,041,138 to Vacanti et al. issued Aug. 29, 1991, U.S. Pat. No.5,197,985 to Caplan et al. issued Mar. 30, 1993, U.S. Pat. No. 5,226,914to Caplan et al. issued Jul. 13, 1993, U.S. Pat. No. 6,328,765 toHardwick et al. issued Dec. 11, 2001, U.S. Pat. No. 6,281,195 to Ruegeret al. issued Aug. 28, 2001, and U.S. Pat. No. 4,846,835 to Grandeissued Jul. 11, 1989. However, clinical outcomes with biologicreplacement materials such as allograft and autograft systems and tissuescaffolds have been uncertain since most of these materials do notachieve a morphologic arrangement or structure similar to or identicalto that of normal, disease-free human tissue it is intended to replace.Moreover, the mechanical durability of these biologic replacementmaterials remains uncertain.

Usually, severe damage or loss of cartilage is treated by replacement ofthe joint with a prosthetic material, for example, silicone, e.g. forcosmetic repairs, or metal alloys. See, e.g., U.S. Pat. No. 6,383,228 toSchmotzer, issued May 7, 2002; U.S. Pat. No. 6,203,576 to Afriat et al.,issued Mar. 20, 2001; U.S. Pat. No. 6,126,690 to Ateshian, et al.,issued Oct. 3, 2000. Implantation of these prosthetic devices is usuallyassociated with loss of underlying tissue and bone without recovery ofthe full function allowed by the original cartilage and, with somedevices, serious long-term complications associated with the loss ofsignificant amount of tissue and bone can include infection, osteolysisand also loosening of the implant.

Further, joint arthroplasties are highly invasive and require surgicalresection of the entire articular surface of one or more bones, or amajority thereof. With these procedures, the marrow space is oftenreamed to fit the stem of the prosthesis. The reaming results in a lossof the patient's bone stock. U.S. Pat. No. 5,593,450 to Scott et al.issued Jan. 14, 1997 discloses an oval domed shaped patella prosthesis.The prosthesis has a femoral component that includes two condyles asarticulating surfaces. The two condyles meet to form a second trochleargroove and ride on a tibial component that articulates with respect tothe femoral component. A patella component is provided to engage thetrochlear groove. U.S. Pat. No. 6,090,144 to Letot et al. issued Jul.18, 2000 discloses a knee prosthesis that includes a tibial componentand a meniscal component that is adapted to be engaged with the tibialcomponent through an asymmetrical engagement.

A variety of materials can be used in replacing a joint with aprosthetic, for example, silicone, e.g. for cosmetic repairs, orsuitable metal alloys are appropriate. See, e.g., U.S. Pat. No.6,443,991 B1 to Running issued Sep. 3, 2002, U.S. Pat. No. 6,387,131 B1to Miehlke et al. issued May 14, 2002; U.S. Pat. No. 6,383,228 toSchmotzer issued May 7, 2002; U.S. Pat. No. 6,344,059 B1 to Krakovits etal. issued Feb. 5, 2002; U.S. Pat. No. 6,203,576 to Afriat et al. issuedMar. 20, 2001; U.S. Pat. No. 6,126,690 to Ateshian et al. issued Oct. 3,2000; U.S. Pat. No. 6,013,103 to Kaufman et al. issued Jan. 11, 2000.Implantation of these prosthetic devices is usually associated with lossof underlying tissue and bone without recovery of the full functionallowed by the original cartilage and, with some devices, seriouslong-term complications associated with the loss of significant amountsof tissue and bone can cause loosening of the implant. One suchcomplication is osteolysis. Once the prosthesis becomes loosened fromthe joint, regardless of the cause, the prosthesis will then need to bereplaced. Since the patient's bone stock is limited, the number ofpossible replacement surgeries is also limited for joint arthroplasty.

As can be appreciated, joint arthroplasties are highly invasive andrequire surgical resection of the entire, or a majority of the,articular surface of one or more bones involved in the repair. Typicallywith these procedures, the marrow space is fairly extensively reamed inorder to fit the stem of the prosthesis within the bone. Reaming resultsin a loss of the patient's bone stock and over time subsequentosteolysis will frequently lead to loosening of the prosthesis. Further,the area where the implant and the bone mate degrades over timerequiring the prosthesis to eventually be replaced. Since the patient'sbone stock is limited, the number of possible replacement surgeries isalso limited for joint arthroplasty. In short, over the course of 15 to20 years, and in some cases even shorter time periods, the patient canrun out of therapeutic options ultimately resulting in a painful,non-functional joint.

U.S. Pat. No. 6,206,927 to Fell, et al., issued Mar. 27, 2001, and U.S.Pat. No. 6,558,421 to Fell, et al., issued May 6, 2003, disclose asurgically implantable knee prosthesis that does not require boneresection. This prosthesis is described as substantially elliptical inshape with one or more straight edges. Accordingly, these devices arenot designed to substantially conform to the actual shape (contour) ofthe remaining cartilage in vivo and/or the underlying bone. Thus,integration of the implant can be extremely difficult due to differencesin thickness and curvature between the patient's surrounding cartilageand/or the underlying subchondral bone and the prosthesis. U.S. Pat. No.6,554,866 to Aicher, et al. issued Apr. 29, 2003 describes amono-condylar knee joint prosthesis.

Interpositional knee devices that are not attached to both the tibia andfemur have been described. For example, Platt et al. (1969) “MouldArthroplasty of the Knee,” Journal of Bone and Joint Surgery51B(1):76-87, describes a hemi-arthroplasty with a convex undersurfacethat was not rigidly attached to the tibia. Devices that are attached tothe bone have also been described. Two attachment designs are commonlyused. The McKeever design is a cross-bar member, shaped like a “t” froma top perspective view, that extends from the bone mating surface of thedevice such that the “t” portion penetrates the bone surface while thesurrounding surface from which the “t” extends abuts the bone surface.See McKeever, “Tibial Plateau Prosthesis,” Chapter 7, p. 86. Analternative attachment design is the Macintosh design, which replacesthe “t” shaped fin for a series of multiple flat serrations or teeth.See Potter, “Arthroplasty of the Knee with Tibial Metallic Implants ofthe McKeever and Macintosh Design,” Surg. Clins. Of North Am. 49(4):903-915 (1969).

U.S. Pat. No. 4,502,161 to Wall issued Mar. 5, 1985, describes aprosthetic meniscus constructed from materials such as silicone rubberor Teflon with reinforcing materials of stainless steel or nylonstrands. U.S. Pat. No. 4,085,466 to Goodfellow et al. issued Mar. 25,1978, describes a meniscal component made from plastic materials.Reconstruction of meniscal lesions has also been attempted withcarbon-fiber-polyurethane-poly (L-lactide). Leeslag, et al., Biologicaland Biomechanical Performance of Biomaterials (Christel et al., eds.)Elsevier Science Publishers B.V., Amsterdam. 1986. pp. 347-352.Reconstruction of meniscal lesions is also possible with bioresorbablematerials and tissue scaffolds.

However, currently available devices do not always provide idealalignment with the articular surfaces and the resultant joint congruity.Poor alignment and poor joint congruity can, for example, lead toinstability of the joint. Further, none of these solutions take intoaccount the fact that roughly 80% of patients undergoing knee surgeryhave a healthy lateral compartment and only need to repair the medialcondyle and the patella. An additional 10% only have damage to thelateral condyle. Thus, 90% of patients do not require the entirecondylar surface repaired.

Thus, there remains a need for compositions for joint repair, includingmethods and compositions that facilitate the integration between thecartilage replacement system and the surrounding cartilage which takesinto account the actual damage to be repaired. Further, there is a needfor an implant or implant system that improves the anatomic result ofthe joint correction procedure by providing surfaces that more closelyresemble the natural knee joint anatomy of a patient. Additionally, whatis needed is an implant or implant system that provides an improvedfunctional joint.

SUMMARY OF THE INVENTION

The present invention provides novel devices and methods for replacing aportion (e.g., diseased area and/or area slightly larger than thediseased area) of a knee joint (e.g., cartilage, meniscus and/or bone)with one or more implants, where the implant(s) achieves an anatomic ornear anatomic fit with the surrounding structures and tissues. In caseswhere the devices and/or methods include an element associated with theunderlying articular bone, the invention also provides that thebone-associated element can achieve a near anatomic alignment with thesubchondral bone. The invention also provides for the preparation of animplantation site with a single cut, or a few relatively small cuts.Asymmetrical components can also be provided to improve the anatomicfunctionality of the repaired joint by providing a solution that closelyresembles the natural knee joint anatomy. The improved anatomic results,in turn, leads to an improved functional result for the repaired joint.The invention also provides a kit which includes one or more implantsused to achieve optimal joint correction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a block diagram of a method for assessing a joint in need ofrepair according to the invention wherein the existing joint surface isunaltered, or substantially unaltered, prior to receiving the selectedimplant. FIG. 1B is a block diagram of a method for assessing a joint inneed of repair according to the invention wherein the existing jointsurface is unaltered, or substantially unaltered, prior to designing animplant suitable to achieve the repair. FIG. 1C is a block diagram of amethod for developing an implant and using the implant in a patient.

FIG. 2A is a perspective view of a joint implant of the inventionsuitable for implantation at the tibial plateau of the knee joint. FIG.2B is a top view of the implant of FIG. 2A. FIG. 2C is a cross-sectionalview of the implant of FIG. 2B along the lines C-C shown in FIG. 2B.FIG. 2D is a cross-sectional view along the lines D-D shown in FIG. 2B.FIG. 2E is a cross-sectional view along the lines E-E shown in FIG. 2B.FIG. 2F is a side view of the implant of FIG. 2A. FIG. 2G is across-sectional view of the implant of FIG. 2A shown implanted takenalong a plane parallel to the sagittal plane. FIG. 2H is across-sectional view of the implant of FIG. 2A shown implanted takenalong a plane parallel to the coronal plane. FIG. 2I is across-sectional view of the implant of FIG. 2A shown implanted takenalong a plane parallel to the axial plane. FIG. 2J shows a slightlylarger implant that extends closer to the bone medially (towards theedge of the tibial plateau) and anteriorly and posteriorly. FIG. 2K is aside view of an alternate embodiment of the joint implant of FIG. 2Ashowing an anchor in the form of a keel. FIG. 2L is a bottom view of analternate embodiment of the joint implant of FIG. 2A showing an anchor.FIG. 2M shows an anchor in the form of a cross-member. FIGS. 2N-O arealternative embodiments of the implant showing the lower surface have atrough for receiving a cross-bar. FIG. 2P illustrates a variety ofcross-bars. FIGS. 2Q-R illustrate the device implanted within a kneejoint. FIG. 2S(1-9) illustrate another implant suitable for the tibialplateau further having a chamfer cut along one edge. FIG. 2T(1-8)illustrate an alternate embodiment of the tibial implant wherein thesurface of the joint is altered to create a flat or angled surface forthe implant to mate with.

FIGS. 3A and B are perspective views of a joint implant suitable for useon a condyle of the femur from the inferior and superior surfaceviewpoints, respectively. FIG. 3C is a side view of the implant of FIG.3A. FIG. 3D is a view of the inferior surface of the implant; FIG. 3E isa view of the superior surface of the implant and FIG. 3F is across-section of the implant. FIG. 3G is an axial view of a femur withthe implant installed thereon. FIG. 3H is an anterior view of the kneejoint without the patella wherein the implant is installed on thefemoral condyle. FIG. 3I is an anterior view of the knee joint with animplant of FIG. 3A implanted on the femoral condyle along with animplant suitable for the tibial plateau, such as that shown in FIG. 2.FIGS. 3J-K illustrate an alternate embodiment of a joint implant for useon a condyle of a femur further having at least one chamfer cut.

FIG. 4A illustrates an implant suitable for the femoral condyleaccording to the prior art. FIGS. 4B-I depict another implant suitablefor placement on a femoral condyle. FIG. 4B is a slightly perspectiveview of the implant from the superior surface. FIG. 4C is a side view ofthe implant of FIG. 4B. FIG. 4D is a top view of the inferior surface ofthe implant; FIGS. 4E and F are perspective side views of the implant.FIG. 4G is an axial view of a femur with the implant installed thereon.FIG. 4H is an anterior view of the knee joint without the patellawherein the implant is installed on the femoral condyle. FIG. 4I is ananterior view of the knee joint with an implant of FIG. 4B implanted onthe femoral condyle along with an implant suitable for the tibialplateau, such as that shown in FIG. 2.

FIGS. 5A-S are depictions of another implant suitable for placement onthe femoral condyle. FIG. 5A is a top view of the inferior surface ofthe implant showing a chamfer cut. FIG. 5B is a slightly perspectiveview of the superior surface of the implant. FIG. 5C is a perspectiveside view of the implant from a first direction; FIG. 5D is a slightlyperspective side view of the implant from a second direction. FIGS. 5E-Fare side views of the implant showing the bearing loads; FIGS. 5G and Hillustrate an alternative embodiment wherein the implant has lateralrails; FIG. 5I illustrates another embodiment wherein the implant has ananchoring keel. FIG. 5J is an axial view of a femur with the implantinstalled on the femoral condyles. FIG. 5K is an anterior view of theknee joint without the patella wherein the implant is installed on thefemoral condyle. FIG. 5L is an anterior view of the knee joint with animplant of FIG. 5A implanted on the femoral condyles along with animplant suitable for the tibial plateau, such as that shown in FIG. 2.FIGS. 5M-N depicts a device implanted within the knee joint. FIG. 5Odepicts an alternate embodiment of the device which accommodates anpartial removal of the condyle. FIGS. 5P-S illustrate alternativeembodiments of the implant having one or more chamfer cuts.

FIGS. 6A-G illustrate a device as shown in FIG. 5 along with a graphicalrepresentation of the cross-sectional data points comprising the surfacemap.

FIGS. 7A-C illustrate an alternate design of a device, suitable for aportion of the femoral condyle, having a two piece configuration.

FIGS. 8A-J depict a whole patella (FIG. 8A) and a patella that has beencut in order to install an implant (FIG. 8B). A top and side view of asuitable patella implant is shown (FIGS. 8C-D), and an illustration ofthe implant superimposed on a whole patella is shown to illustrate thelocation of the implant dome relative to the patellar ridge. FIGS. 8E-Fillustrate the implant superimposed over a patella. FIGS. 8G-Jillustrate an alternate design for the patella implant based on a blank(FIG. 8G).

FIGS. 9A-C depict representative side views of a knee joint with any ofthe devices taught installed therein. FIG. 9A depicts the knee with acondyle implant and a patella implant. FIG. 9B depicts an alternate viewof the knee with a condyle implant and a patella implant wherein thecondyle implant covers a greater portion of the surface of the condylein the posterior direction. FIG. 9C illustrates a knee joint wherein theimplant is provided on the condyle, the patella and the tibial plateau.

FIGS. 10A-D depict a frontal view of the knee joint with any of thedevices taught installed therein. FIG. 10A depicts the knee with atibial implant. FIG. 10B depicts the knee with a condyle implant. FIG.10C depicts a knee with a tibial implant and a condyle implant. FIG. 10Cdepicts a knee with a bicompartmental condyle implant and a tibialimplant.

DETAILED DESCRIPTION OF THE INVENTION

The following description is presented to enable any person skilled inthe art to make and use the invention. Various modifications to theembodiments described will be readily apparent to those skilled in theart, and the generic principles defined herein can be applied to otherembodiments and applications without departing from the spirit and scopeof the present invention as defined by the appended claims. Thus, thepresent invention is not intended to be limited to the embodimentsshown, but is to be accorded the widest scope consistent with theprinciples and features disclosed herein. To the extent necessary toachieve a complete understanding of the invention disclosed, thespecification and drawings of all issued patents, patent publications,and patent applications cited in this application are incorporatedherein by reference.

As will be appreciated by those of skill in the art, methods recitedherein may be carried out in any order of the recited events which islogically possible, as well as the recited order of events. Furthermore,where a range of values is provided, it is understood that everyintervening value, between the upper and lower limit of that range andany other stated or intervening value in that stated range isencompassed within the invention. Also, it is contemplated that anyoptional feature of the inventive variations described may be set forthand claimed independently, or in combination with any one or more of thefeatures described herein.

The practice of the present invention can employ, unless otherwiseindicated, conventional and digital methods of x-ray imaging andprocessing, x-ray tomosynthesis, ultrasound including A-scan, B-scan andC-scan, computed tomography (CT scan), magnetic resonance imaging (MRI),optical coherence tomography, single photon emission tomography (SPECT)and positron emission tomography (PET) within the skill of the art. Suchtechniques are explained fully in the literature and need not bedescribed herein. See, e.g., X-Ray Structure Determination: A PracticalGuide, 2nd Edition, editors Stout and Jensen, 1989, John Wiley & Sons,publisher; Body CT: A Practical Approach, editor Slone, 1999,McGraw-Hill publisher; X-ray Diagnosis: A Physician's Approach, editorLam, 1998 Springer-Verlag, publisher; and Dental Radiology:Understanding the X-Ray Image, editor Laetitia Brocklebank 1997, OxfordUniversity Press publisher. See also, The Essential Physics of MedicalImaging (2^(nd) Ed.), Jerrold T. Bushberg, et al.

The present invention provides methods and compositions for repairingjoints, particularly for repairing articular cartilage and forfacilitating the integration of a wide variety of cartilage repairmaterials into a subject. Among other things, the techniques describedherein allow for the customization of cartilage repair material to suita particular subject, for example in terms of size, cartilage thicknessand/or curvature. When the shape (e.g., size, thickness and/orcurvature) of the articular cartilage surface is an exact or nearanatomic fit with the non-damaged cartilage or with the subject'soriginal cartilage, the success of repair is enhanced. The repairmaterial can be shaped prior to implantation and such shaping can bebased, for example, on electronic images that provide informationregarding curvature or thickness of any “normal” cartilage surroundingthe defect and/or on curvature of the bone underlying the defect. Thus,the current invention provides, among other things, for minimallyinvasive methods for partial joint replacement. The methods will requireonly minimal or, in some instances, no loss in bone stock. Additionally,unlike with current techniques, the methods described herein will helpto restore the integrity of the articular surface by achieving an exactor near anatomic match between the implant and the surrounding oradjacent cartilage and/or subchondral bone.

Advantages of the present invention can include, but are not limited to,(i) customization of joint repair, thereby enhancing the efficacy andcomfort level for the patient following the repair procedure; (ii)eliminating the need for a surgeon to measure the defect to be repairedintraoperatively in some embodiments; (iii) eliminating the need for asurgeon to shape the material during the implantation procedure; (iv)providing methods of evaluating curvature of the repair material basedon bone or tissue images or based on intraoperative probing techniques;(v) providing methods of repairing joints with only minimal or, in someinstances, no loss in bone stock; (vi) improving postoperative jointcongruity; (vii) improving the postoperative patient recovery in someembodiments and (viii) improving postoperative function, such as rangeof motion.

Thus, the methods described herein allow for the design and use of jointrepair material that more precisely fits the defect (e.g., site ofimplantation) or the articular surface(s) and, accordingly, providesimproved repair of the joint.

I. Assessment of Joints and Alignment

The methods and compositions described herein can be used to treatdefects resulting from disease of the cartilage (e.g., osteoarthritis),bone damage, cartilage damage, trauma, and/or degeneration due tooveruse or age. The invention allows, among other things, a healthpractitioner to evaluate and treat such defects. The size, volume andshape of the area of interest can include only the region of cartilagethat has the defect, but preferably will also include contiguous partsof the cartilage surrounding the cartilage defect.

As will be appreciated by those of skill in the art, size, curvatureand/or thickness measurements can be obtained using any suitabletechnique. For example, one-dimensional, two-dimensional, and/orthree-dimensional measurements can be obtained using suitable mechanicalmeans, laser devices, electromagnetic or optical tracking systems,molds, materials applied to the articular surface that harden and“memorize the surface contour,” and/or one or more imaging techniquesknown in the art. Measurements can be obtained non-invasively and/orintraoperatively (e.g., using a probe or other surgical device). As willbe appreciated by those of skill in the art, the thickness of the repairdevice can vary at any given point depending upon patient's anatomyand/or the depth of the damage to the cartilage and/or bone to becorrected at any particular location on an articular surface.

FIG. 1A is a flow chart showing steps taken by a practitioner inassessing a joint. First, a practitioner obtains a measurement of atarget joint 10. The step of obtaining a measurement can be accomplishedby taking an image of the joint. This step can be repeated, asnecessary, 11 to obtain a plurality of images in order to further refinethe joint assessment process. Once the practitioner has obtained thenecessary measurements, the information is used to generate a modelrepresentation of the target joint being assessed 30. This modelrepresentation can be in the form of a topographical map or image. Themodel representation of the joint can be in one, two, or threedimensions. It can include a physical model. More than one model can becreated 31, if desired. Either the original model, or a subsequentlycreated model, or both can be used. After the model representation ofthe joint is generated 30, the practitioner can optionally generate aprojected model representation of the target joint in a correctedcondition 40, e.g., from the existing cartilage on the joint surface, byproviding a mirror of the opposing joint surface, or a combinationthereof. Again, this step can be repeated 41, as necessary or desired.Using the difference between the topographical condition of the jointand the projected image of the joint, the practitioner can then select ajoint implant 50 that is suitable to achieve the corrected jointanatomy. As will be appreciated by those of skill in the art, theselection process 50 can be repeated 51 as often as desired to achievethe desired result. Additionally, it is contemplated that a practitionercan obtain a measurement of a target joint 10 by obtaining, for example,an x-ray, and then select a suitable joint replacement implant 50.

As will be appreciated by those of skill in the art, the practitionercan proceed directly from the step of generating a model representationof the target joint 30 to the step of selecting a suitable jointreplacement implant 50 as shown by the arrow 32. Additionally, followingselection of suitable joint replacement implant 50, the steps ofobtaining measurement of target joint 10, generating modelrepresentation of target joint 30 and generating projected model 40, canbe repeated in series or parallel as shown by the flow 24, 25, 26.

FIG. 1B is an alternate flow chart showing steps taken by a practitionerin assessing a joint. First, a practitioner obtains a measurement of atarget joint 10. The step of obtaining a measurement can be accomplishedby taking an image of the joint. This step can be repeated, asnecessary, 11 to obtain a plurality of images in order to further refinethe joint assessment process. Once the practitioner has obtained thenecessary measurements, the information is used to generate a modelrepresentation of the target joint being assessed 30. This modelrepresentation can be in the form of a topographical map or image. Themodel representation of the joint can be in one, two, or threedimensions. The process can be repeated 31 as necessary or desired. Itcan include a physical model. After the model representation of thejoint is assessed 30, the practitioner can optionally generate aprojected model representation of the target joint in a correctedcondition 40. This step can be repeated 41 as necessary or desired.Using the difference between the topographical condition of the jointand the projected image of the joint, the practitioner can then design ajoint implant 52 that is suitable to achieve the corrected jointanatomy, repeating the design process 53 as often as necessary toachieve the desired implant design. The practitioner can also assesswhether providing additional features, such as rails, keels, lips, pegs,cruciate stems, or anchors, cross-bars, etc. will enhance the implants'performance in the target joint.

As will be appreciated by those of skill in the art, the practitionercan proceed directly from the step of generating a model representationof the target joint 30 to the step of designing a suitable jointreplacement implant 52 as shown by the arrow 38. Similar to the flowshown above, following the design of a suitable joint replacementimplant 52, the steps of obtaining measurement of target joint 10,generating model representation of target joint 30 and generatingprojected model 40, can be repeated in series or parallel as shown bythe flow 42, 43, 44.

FIG. 1C is a flow chart illustrating the process of selecting an implantfor a patient. First, using the techniques described above or thosesuitable and known in the art at the time the invention is practiced,the size of area of diseased cartilage or cartilage loss is measured100. This step can be repeated multiple times 101, as desired. Once thesize of the cartilage defect is measured, the thickness of adjacentcartilage can optionally be measured 110. This process can also berepeated as desired 111. Either after measuring the cartilage loss ormeasuring the thickness of adjacent cartilage, the curvature of thearticular surface is then measured 120. Alternatively, the subchondralbone can be measured. As will be appreciated measurements can be takenof the surface of the joint being repaired, or of the mating surface inorder to facilitate development of the best design for the implantsurface.

Once the surfaces have been measured, the user either selects the bestfitting implant contained in a library of implants 130 or generates apatient-specific implant 132. These steps can be repeated as desired ornecessary to achieve the best fitting implant for a patient, 131, 133.As will be appreciated by those of skill in the art, the process ofselecting or designing an implant can be tested against the informationcontained in the MRI or x-ray of the patient to ensure that the surfacesof the device achieves a good fit relative to the patient's jointsurface. Testing can be accomplished by, for example, superimposing theimplant image over the image for the patient's joint. Once it has beendetermined that a suitable implant has been selected or designed, theimplant site can be prepared 140, for example by removing cartilage orbone from the joint surface, or the implant can be placed into the joint150.

The joint implant selected or designed achieves anatomic or nearanatomic fit with the existing surface of the joint while presenting amating surface for the opposing joint surface that replicates thenatural joint anatomy. In this instance, both the existing surface ofthe joint can be assessed as well as the desired resulting surface ofthe joint. This technique is particularly useful for implants that arenot anchored into the bone.

As will be appreciated by those of skill in the art, the physician, orother person practicing the invention, can obtain a measurement of atarget joint 10 and then either design 52 or select 50 a suitable jointreplacement implant.

Ii. Repair Materials

A wide variety of materials find use in the practice of the presentinvention, including, but not limited to, plastics, metals, crystal freemetals, ceramics, biological materials (e.g., collagen or otherextracellular matrix materials), hydroxyapatite, cells (e.g., stemcells, chondrocyte cells or the like), or combinations thereof. Based onthe information (e.g., measurements) obtained regarding the defect andthe articular surface and/or the subchondral bone, a repair material canbe formed or selected. Further, using one or more of these techniquesdescribed herein, a cartilage replacement or regenerating materialhaving a curvature that will fit into a particular cartilage defect,will follow the contour and shape of the articular surface, and willmatch the thickness of the surrounding cartilage. The repair materialcan include any combination of materials, and typically includes atleast one non-pliable material, for example materials that are noteasily bent or changed.

A. Metal and Polymeric Repair Materials

Currently, joint repair systems often employ metal and/or polymericmaterials including, for example, prostheses which are anchored into theunderlying bone (e.g., a femur in the case of a knee prosthesis). See,e.g., U.S. Pat. No. 6,203,576 to Afriat, et al. issued Mar. 20, 2001 and6,322,588 to Ogle, et al. issued Nov. 27, 2001, and references citedtherein. A wide-variety of metals are useful in the practice of thepresent invention, and can be selected based on any criteria. Forexample, material selection can be based on resiliency to impart adesired degree of rigidity. Non-limiting examples of suitable metalsinclude silver, gold, platinum, palladium, iridium, copper, tin, lead,antimony, bismuth, zinc, titanium, cobalt, stainless steel, nickel, ironalloys, cobalt alloys, such as Elgiloy®, a cobalt-chromium-nickel alloy,and MP35N, a nickel-cobalt-chromium-molybdenum alloy, and Nitinol™, anickel-titanium alloy, aluminum, manganese, iron, tantalum, crystal freemetals, such as Liquidmetal® alloys (available from LiquidMetalTechnologies, www.liauidmetal.com), other metals that can slowly formpolyvalent metal ions, for example to inhibit calcification of implantedsubstrates in contact with a patient's bodily fluids or tissues, andcombinations thereof.

Suitable synthetic polymers include, without limitation, polyamides(e.g., nylon), polyesters, polystyrenes, polyacrylates, vinyl polymers(e.g., polyethylene, polytetrafluoroethylene, polypropylene andpolyvinyl chloride), polycarbonates, polyurethanes, poly dimethylsiloxanes, cellulose acetates, polymethyl methacrylates, polyether etherketones, ethylene vinyl acetates, polysulfones, nitrocelluloses, similarcopolymers and mixtures thereof. Bioresorbable synthetic polymers canalso be used such as dextran, hydroxyethyl starch, derivatives ofgelatin, polyvinylpyrrolidone, polyvinyl alcohol,poly[N-(2-hydroxypropyl) methacrylamide], poly(hydroxy acids),poly(epsilon-caprolactone), polylactic acid, polyglycolic acid,poly(dimethyl glycolic acid), poly(hydroxy butyrate), and similarcopolymers can also be used.

Other materials would also be appropriate, for example, the polyketoneknown as polyetheretherketone (PEEK™). This includes the material PEEK450G, which is an unfilled PEEK approved for medical implantationavailable from Victrex of Lancashire, Great Britain. (Victrex is locatedat www.matweb.com or see Boedeker www.boedeker.com). Other sources ofthis material include Gharda located in Panoli, India(www.ghardapolymers.com).

It should be noted that the material selected can also be filled. Forexample, other grades of PEEK are also available and contemplated, suchas 30% glass-filled or 30% carbon filled, provided such materials arecleared for use in implantable devices by the FDA, or other regulatorybody. Glass filled PEEK reduces the expansion rate and increases theflexural modulus of PEEK relative to that portion which is unfilled. Theresulting product is known to be ideal for improved strength, stiffness,or stability. Carbon filled PEEK is known to enhance the compressivestrength and stiffness of PEEK and lower its expansion rate. Carbonfilled PEEK offers wear resistance and load carrying capability.

As will be appreciated, other suitable similarly biocompatiblethermoplastic or thermoplastic polycondensate materials that resistfatigue, have good memory, are flexible, and/or deflectable have verylow moisture absorption, and good wear and/or abrasion resistance, canbe used without departing from the scope of the invention. The implantcan also be comprised of polyetherketoneketone (PEKK).

Other materials that can be used include polyetherketone (PEK),polyetherketoneetherketoneketone (PEKEKK), andpolyetheretherketoneketone (PEEKK), and generally apolyaryletheretherketone. Further other polyketones can be used as wellas other thermoplastics.

Reference to appropriate polymers that can be used for the implant canbe made to the following documents, all of which are incorporated hereinby reference. These documents include: PCT Publication WO 02/02158 A1,dated Jan. 10, 2002 and entitled Bio-Compatible Polymeric Materials; PCTPublication WO 02/00275 A1, dated Jan. 3, 2002 and entitledBio-Compatible Polymeric Materials; and PCT Publication WO 02/00270 A1,dated Jan. 3, 2002 and entitled Bio-Compatible Polymeric Materials.

The polymers can be prepared by any of a variety of approaches includingconventional polymer processing methods. Preferred approaches include,for example, injection molding, which is suitable for the production ofpolymer components with significant structural features, and rapidprototyping approaches, such as reaction injection molding andstereo-lithography. The substrate can be textured or made porous byeither physical abrasion or chemical alteration to facilitateincorporation of the metal coating. Other processes are alsoappropriate, such as extrusion, injection, compression molding and/ormachining techniques. Typically, the polymer is chosen for its physicaland mechanical properties and is suitable for carrying and spreading thephysical load between the joint surfaces.

More than one metal and/or polymer can be used in combination with eachother. For example, one or more metal-containing substrates can becoated with polymers in one or more regions or, alternatively, one ormore polymer-containing substrate can be coated in one or more regionswith one or more metals.

The system or prosthesis can be porous or porous coated. The poroussurface components can be made of various materials including metals,ceramics, and polymers. These surface components can, in turn, besecured by various means to a multitude of structural cores formed ofvarious metals. Suitable porous coatings include, but are not limitedto, metal, ceramic, polymeric (e.g., biologically neutral elastomerssuch as silicone rubber, polyethylene terephthalate and/or combinationsthereof) or combinations thereof. See, e.g., U.S. Pat. No. 3,605,123 toHahn, issued Sep. 20, 1971. U.S. Pat. No. 3,808,606 to Tronzo issued May7, 1974 and U.S. Pat. No. 3,843,975 to Tronzo issued Oct. 29, 1974; U.S.Pat. No. 3,314,420 to Smith issued Apr. 18, 1967; U.S. Pat. No.3,987,499 to Scharbach issued Oct. 26, 1976; and GermanOffenlegungsschrift 2,306,552. There can be more than one coating layerand the layers can have the same or different porosities. See, e.g.,U.S. Pat. No. 3,938,198 to Kahn, et al., issued Feb. 17, 1976.

The coating can be applied by surrounding a core with powdered polymerand heating until cured to form a coating with an internal network ofinterconnected pores. The tortuosity of the pores (e.g., a measure oflength to diameter of the paths through the pores) can be important inevaluating the probable success of such a coating in use on a prostheticdevice. See, also, U.S. Pat. No. 4,213,816 to Morris issued Jul. 22,1980. The porous coating can be applied in the form of a powder and thearticle as a whole subjected to an elevated temperature that bonds thepowder to the substrate. Selection of suitable polymers and/or powdercoatings can be determined in view of the teachings and references citedherein, for example based on the melt index of each.

B. Biological Repair Material

Repair materials can also include one or more biological material eitheralone or in combination with non-biological materials. For example, anybase material can be designed or shaped and suitable cartilagereplacement or regenerating material(s) such as fetal cartilage cellscan be applied to be the base. The cells can be then be grown inconjunction with the base until the thickness (and/or curvature) of thecartilage surrounding the cartilage defect has been reached. Conditionsfor growing cells (e.g., chondrocytes) on various substrates in culture,ex vivo and in vivo are described, for example, in U.S. Pat. Nos.5,478,739 to Slivka et al. issued Dec. 26, 1995; 5,842,477 to Naughtonet al. issued Dec. 1, 1998; 6,283,980 to Vibe-Hansen et al., issued Sep.4, 2001, and 6,365,405 to Salzmann et al. issued Apr. 2, 2002.Non-limiting examples of suitable substrates include plastic, tissuescaffold, a bone replacement material (e.g., a hydroxyapatite, abioresorbable material), or any other material suitable for growing acartilage replacement or regenerating material on it.

Biological polymers can be naturally occurring or produced in vitro byfermentation and the like. Suitable biological polymers include, withoutlimitation, collagen, elastin, silk, keratin, gelatin, polyamino acids,cat gut sutures, polysaccharides (e.g., cellulose and starch) andmixtures thereof. Biological polymers can be bioresorbable.

Biological materials used in the methods described herein can beautografts (from the same subject); allografts (from another individualof the same species) and/or xenografts (from another species). See,also, International Patent Publications WO 02/22014 to Alexander et al.published Mar. 21, 2002 and WO 97/27885 to Lee published Aug. 7, 1997.In certain embodiments autologous materials are preferred, as they cancarry a reduced risk of immunological complications to the host,including re-absorption of the materials, inflammation and/or scarringof the tissues surrounding the implant site.

In one embodiment of the invention, a probe is used to harvest tissuefrom a donor site and to prepare a recipient site. The donor site can belocated in a xenograft, an allograft or an autograft. The probe is usedto achieve a good anatomic match between the donor tissue sample and therecipient site. The probe is specifically designed to achieve a seamlessor near seamless match between the donor tissue sample and the recipientsite. The probe can, for example, be cylindrical. The distal end of theprobe is typically sharp in order to facilitate tissue penetration.Additionally, the distal end of the probe is typically hollow in orderto accept the tissue. The probe can have an edge at a defined distancefrom its distal end, e.g. at 1 cm distance from the distal end and theedge can be used to achieve a defined depth of tissue penetration forharvesting. The edge can be external or can be inside the hollow portionof the probe. For example, an orthopedic surgeon can take the probe andadvance it with physical pressure into the cartilage, the subchondralbone and the underlying marrow in the case of a joint such as a kneejoint. The surgeon can advance the probe until the external or internaledge reaches the cartilage surface. At that point, the edge will preventfurther tissue penetration thereby achieving a constant and reproducibletissue penetration. The distal end of the probe can include one or moreblades, saw-like structures, or tissue cutting mechanism. For example,the distal end of the probe can include an iris-like mechanismconsisting of several small blades. The blade or blades can be movedusing a manual, motorized or electrical mechanism thereby cuttingthrough the tissue and separating the tissue sample from the underlyingtissue. Typically, this will be repeated in the donor and the recipient.In the case of an iris-shaped blade mechanism, the individual blades canbe moved so as to close the iris thereby separating the tissue samplefrom the donor site.

In another embodiment of the invention, a laser device or aradiofrequency device can be integrated inside the distal end of theprobe. The laser device or the radiofrequency device can be used to cutthrough the tissue and to separate the tissue sample from the underlyingtissue.

In one embodiment of the invention, the same probe can be used in thedonor and in the recipient. In another embodiment, similarly shapedprobes of slightly different physical dimensions can be used. Forexample, the probe used in the recipient can be slightly smaller thanthat used in the donor thereby achieving a tight fit between the tissuesample or tissue transplant and the recipient site. The probe used inthe recipient can also be slightly shorter than that used in the donorthereby correcting for any tissue lost during the separation or cuttingof the tissue sample from the underlying tissue in the donor material.

Any biological repair material can be sterilized to inactivatebiological contaminants such as bacteria, viruses, yeasts, molds,mycoplasmas and parasites. Sterilization can be performed using anysuitable technique, for example radiation, such as gamma radiation.

Any of the biological materials described herein can be harvested withuse of a robotic device. The robotic device can use information from anelectronic image for tissue harvesting.

In certain embodiments, the cartilage replacement material has aparticular biochemical composition. For instance, the biochemicalcomposition of the cartilage surrounding a defect can be assessed bytaking tissue samples and chemical analysis or by imaging techniques.For example, WO 02/22014 to Alexander describes the use of gadoliniumfor imaging of articular cartilage to monitor glycosaminoglycan contentwithin the cartilage. The cartilage replacement or regenerating materialcan then be made or cultured in a manner, to achieve a biochemicalcomposition similar to that of the cartilage surrounding theimplantation site. The culture conditions used to achieve the desiredbiochemical compositions can include, for example, varyingconcentrations. Biochemical composition of the cartilage replacement orregenerating material can, for example, be influenced by controllingconcentrations and exposure times of certain nutrients and growthfactors.

III. Device Design

A. Cartilage Models

Using information on thickness and curvature of the cartilage, aphysical model of the surfaces of the articular cartilage and of theunderlying bone can be created. This physical model can berepresentative of a limited area within the joint or it can encompassthe entire joint. This model can also take into consideration thepresence or absence of a meniscus as well as the presence or absence ofsome or all of the cartilage. For example, in the knee joint, thephysical model can encompass only the medial or lateral femoral condyle,both femoral condyles and the notch region, the medial tibial plateau,the lateral tibial plateau, the entire tibial plateau, the medialpatella, the lateral patella, the entire patella or the entire joint.The location of a diseased area of cartilage can be determined, forexample using a 3D coordinate system or a 3D Euclidian distance asdescribed in WO 02/22014.

In this way, the size of the defect to be repaired can be determined.This process takes into account that, for example, roughly 80% ofpatients have a healthy lateral component. As will be apparent, some,but not all, defects will include less than the entire cartilage. Thus,in one embodiment of the invention, the thickness of the normal or onlymildly diseased cartilage surrounding one or more cartilage defects ismeasured. This thickness measurement can be obtained at a single pointor, preferably, at multiple points, for example 2 point, 4-6 points,7-10 points, more than 10 points or over the length of the entireremaining cartilage. Furthermore, once the size of the defect isdetermined, an appropriate therapy (e.g., articular repair system) canbe selected such that as much as possible of the healthy, surroundingtissue is preserved.

In other embodiments, the curvature of the articular surface can bemeasured to design and/or shape the repair material. Further, both thethickness of the remaining cartilage and the curvature of the articularsurface can be measured to design and/or shape the repair material.Alternatively, the curvature of the subchondral bone can be measured andthe resultant measurement(s) can be used to either select or shape acartilage replacement material. For example, the contour of thesubchondral bone can be used to re-create a virtual cartilage surface:the margins of an area of diseased cartilage can be identified. Thesubchondral bone shape in the diseased areas can be measured. A virtualcontour can then be created by copying the subchondral bone surface intothe cartilage surface, whereby the copy of the subchondral bone surfaceconnects the margins of the area of diseased cartilage. In shaping thedevice, the contours can be configured to mate with existing cartilageor to account for the removal of some or all of the cartilage.

FIG. 2A shows a slightly perspective top view of a joint implant 200 ofthe invention suitable for implantation at the tibial plateau of theknee joint. As shown in FIG. 2A, the implant can be generated using, forexample, a dual surface assessment, as described above with respect toFIGS. 1A and B.

The implant 200 has an upper surface 202, a lower surface 204 and aperipheral edge 206. The upper surface 202 is formed so that it forms amating surface for receiving the opposing joint surface; in thisinstance partially concave to receive the femur. The concave surface canbe variably concave such that it presents a surface to the opposingjoint surface, e.g. a negative surface of the mating surface of thefemur it communicates with. As will be appreciated by those of skill inthe art, the negative impression, need not be a perfect one.

The upper surface 202 of the implant 200 can be shaped by any of avariety of means. For example, the upper surface 202 can be shaped byprojecting the surface from the existing cartilage and/or bone surfaceson the tibial plateau, or it can be shaped to mirror the femoral condylein order to optimize the complimentary surface of the implant when itengages the femoral condyle. Alternatively, the superior surface 202 canbe configured to mate with an inferior surface of an implant configuredfor the opposing femoral condyle.

The lower surface 204 has a convex surface that matches, or nearlymatches, the tibial plateau of the joint such that it creates ananatomic or near anatomic fit with the tibial plateau. Depending on theshape of the tibial plateau, the lower surface can be partially convexas well. Thus, the lower surface 204 presents a surface to the tibialplateau that fits within the existing surface. It can be formed to matchthe existing surface or to match the surface after articularresurfacing.

As will be appreciated by those of skill in the art, the convex surfaceof the lower surface 204 need not be perfectly convex. Rather, the lowersurface 204 is more likely consist of convex and concave portions thatfit within the existing surface of the tibial plateau or the re-surfacedplateau. Thus, the surface is essentially variably convex and concave.

FIG. 2B shows a top view of the joint implant of FIG. 2A. As shown inFIG. 2B the exterior shape 208 of the implant can be elongated. Theelongated form can take a variety of shapes including elliptical,quasi-elliptical, race-track, etc. However, as will be appreciated theexterior dimension is typically irregular thus not forming a truegeometric shape, e.g. ellipse. As will be appreciated by those of skillin the art, the actual exterior shape of an implant can vary dependingon the nature of the joint defect to be corrected. Thus the ratio of thelength L to the width W can vary from, for example, between 0.25 to 2.0,and more specifically from 0.5 to 1.5. As further shown in FIG. 2B, thelength across an axis of the implant 200 varies when taken at pointsalong the width of the implant. For example, as shown in FIG. 2B,L₁≠L₂≠L₃.

Turning now to FIGS. 2C-E, cross-sections of the implant shown in FIG.2B are depicted along the lines of C-C, D-D, and E-E. The implant has athickness t1, t2 and t3 respectively. As illustrated by thecross-sections, the thickness of the implant varies along both itslength L and width W. The actual thickness at a particular location ofthe implant 200 is a function of the thickness of the cartilage and/orbone to be replaced and the joint mating surface to be replicated.Further, the profile of the implant 200 at any location along its lengthL or width W is a function of the cartilage and/or bone to be replaced.

FIG. 2F is a lateral view of the implant 200 of FIG. 2A. In thisinstance, the height of the implant 200 at a first end h₁ is differentthan the height of the implant at a second end h₂. Further the upperedge 208 can have an overall slope in a downward direction. However, asillustrated the actual slope of the upper edge 208 varies along itslength and can, in some instances, be a positive slope. Further thelower edge 210 can have an overall slope in a downward direction. Asillustrated the actual slope of the lower edge 210 varies along itslength and can, in some instances, be a positive slope. As will beappreciated by those of skill in the art, depending on the anatomy of anindividual patient, an implant can be created wherein h₁ and h₂ areequivalent, or substantially equivalent without departing from the scopeof the invention.

FIG. 2G is a cross-section taken along a sagittal plane in a bodyshowing the implant 200 implanted within a knee joint 1020 such that thelower surface 204 of the implant 200 lies on the tibial plateau 1022 andthe femur 1024 rests on the upper surface 202 of the implant 200. FIG.2H is a cross-section taken along a coronal plane in a body showing theimplant 200 implanted within a knee joint 1020. As is apparent from thisview, the implant 200 is positioned so that it fits within a superiorarticular surface 224. As will be appreciated by those of skill in theart, the articular surface could be the medial or lateral facet, asneeded.

FIG. 2I is a view along an axial plane of the body showing the implant200 implanted within a knee joint 1020 showing the view taken from anaerial, or upper, view. FIG. 2J is a view of an alternate embodimentwhere the implant is a bit larger such that it extends closer to thebone medially, i.e. towards the edge 1023 of the tibial plateau, as wellas extending anteriorly and posteriorly.

FIG. 2K is a cross-section of an implant 200 of the invention accordingto an alternate embodiment. In this embodiment, the lower surface 204further includes a joint anchor 212. As illustrated in this embodiment,the joint anchor 212 forms a protrusion, keel or vertical member thatextends from the lower surface 204 of the implant 200 and projects into,for example, the bone of the joint. As will be appreciated by those ofskill in the art, the keel can be perpendicular or lie within a plane ofthe body.

Additionally, as shown in FIG. 2L the joint anchor 212 can have across-member 214 so that from a bottom perspective, the joint anchor 212has the appearance of a cross or an “x.” As will be appreciated by thoseof skill in the art, the joint anchor 212 could take on a variety ofother forms while still accomplishing the same objective of providingincreased stability of the implant 200 in the joint. These formsinclude, but are not limited to, pins, bulbs, balls, teeth, etc.Additionally, one or more joint anchors 212 can be provided as desired.FIGS. 2M and N illustrate cross-sections of alternate embodiments of adual component implant from a side view and a front view.

In an alternate embodiment shown in FIG. 2M it may be desirable toprovide a one or more cross-members 220 on the lower surface 204 inorder to provide a bit of translation movement of the implant relativeto the surface of the femur, or femur implant. In that event, thecross-member can be formed integral to the surface of the implant or canbe one or more separate pieces that fit within a groove 222 on the lowersurface 204 of the implant 200. The groove can form a single channel asshown in FIG. 2N1, or can have more than one channel as shown in FIG.2N2. In either event, the cross-bar then fits within the channel asshown in FIGS. 2N1-N2. The cross-bar members 220 can form a solid orhollow tube or pipe structure as shown in FIG. 2P. Where two, or more,tubes 220 communicate to provide translation, a groove 221 can beprovided along the surface of one or both cross-members to interlock thetubes into a cross-bar member further stabilizing the motion of thecross-bar relative to the implant 200. As will be appreciated by thoseof skill in the art, the cross-bar member 220 can be formed integrallywith the implant without departing from the scope of the invention.

As shown in FIGS. 2Q-R, it is anticipated that the surface of the tibialplateau will be prepared by forming channels thereon to receive thecross-bar members. Thus facilitating the ability of the implant to seatsecurely within the joint while still providing movement about an axiswhen the knee joint is in motion.

FIGS. 2S(1-9) illustrate an alternate embodiment of implant 200. Asillustrated in FIG. 2S the edges are beveled to relax a sharp corner.FIG. 2S(1) illustrates an implant having a single fillet or bevel 230.The fillet is placed on the implant anterior to the posterior portion ofthe tibial spine. As shown in FIG. 2S(2) two fillets 230, 231 areprovided and used for the posterior chamfer. In FIG. 2S(3) a thirdfillet 234 is provided to create two cut surfaces for the posteriorchamfer.

Turning now to FIG. 2S(4) a tangent of the implant is deselected,leaving three posterior curves. FIG. 2S(5) shows the result of tangentpropagation. FIG. 2S(6) illustrates the effect on the design when thebottom curve is selected without tangent propagation. The result oftangent propagation and selection is shown in FIG. 2S(7). As can be seenin FIG. 2S(8-9) the resulting corner has a softer edge but sacrificesless than 0.5 mm of joint space. As will be appreciated by those ofskill in the art, additional cutting planes can be added withoutdeparting from the scope of the invention.

FIG. 2T illustrates an alternate embodiment of an implant 200 whereinthe surface of the tibial plateau 250 is altered to accommodate theimplant. As illustrated in FIG. 2T(1-2) the tibial plateau can bealtered for only half of the joint surface 251 or for the full surface252. As illustrate in FIG. 2T(3-4) the posterior-anterior surface can beflat 260 or graded 262. Grading can be either positive or negativerelative to the anterior surface. Grading can also be used with respectto the implants of FIG. 2T where the grading either lies within a planeor a body or is angled relative to a plane of the body. Additionally,attachment mechanisms can be provided to anchor the implant to thealtered surface. As shown in FIG. 2T(5-7) keels 264 can be provided. Thekeels 264 can either sit within a plane, e.g. sagittal or coronal plane,or not sit within a plane (as shown in FIG. 2T(7)). FIG. 2T(8)illustrates an implant which covers the entire tibial plateau. The uppersurface of these implants are designed to conform to the projected shapeof the joint as determined under the steps described with respect toFIG. 1, while the lower surface is designed to be flat, or substantiallyflat to correspond to the modified surface of the joint.

Turning now to FIGS. 3A-I an implant suitable for providing an opposingjoint surface to the implant of FIG. 2A is shown. This implant correctsa defect on an inferior surface of the femur 1024 (e.g., the condyle ofthe femur that mates with the tibial plateau) and can be used alone,i.e., on the femur 1024, or in combination with another joint repairdevice. Formation of the surfaces of the devices can be achieved usingthe techniques described above with respect to the implant of FIG. 2.

FIG. 3A shows a perspective view of an implant 300 having a curvedmating surface 302 and convex joint abutting surface 304. The jointabutting surface 304 need not form an anatomic or near anatomic fit withthe femur in view of the anchors 306 provided to facilitate connectionof the implant to the bone. In this instance, the anchors 306 are shownas pegs having notched heads. The notches facilitate the anchoringprocess within the bone. However, pegs without notches can be used aswell as pegs with other configurations that facilitate the anchoringprocess or cruciate stems. Pegs and other portions of the implant can beporous coated. The implant can be inserted without bone cement or withuse of bone cement. The implant can be designed to abut the subchondralbone, i.e. it can substantially follow the contour of the subchondralbone. This has the advantage that no bone needs to be removed other thanfor the placement of the peg holes thereby significantly preserving bonestock.

The anchors 306 could take on a variety of other forms without departingfrom the scope of the invention while still accomplishing the sameobjective of providing increased stability of the implant 300 in thejoint. These forms include, but are not limited to, pins, bulbs, balls,teeth, etc. Additionally, one or more joint anchors 306 can be providedas desired. As illustrated in FIG. 3, three pins are used to anchor theimplant 300. However, more or fewer joint anchors, cruciate stems, orpins, can be used without departing from the scope of the invention.

FIG. 3B shows a slightly perspective superior view of the bone matingsurface 304 further illustrating the use of three anchors 306 to anchorthe implant to the bone. Each anchor 306 has a stem 310 with a head 312on top. As shown in FIG. 3C, the stem 310 has parallel walls such thatit forms a tube or cylinder that extends from the bone mating surface304. A section of the stem forms a narrowed neck 314 proximal to thehead 312. As will be appreciated by those of skill in the art, the wallsneed not be parallel, but rather can be sloped to be shaped like a cone.Additionally, the neck 314 need not be present, nor the head 312. Asdiscussed above, other configurations suitable for anchoring can be usedwithout departing from the scope of the invention.

Turning now to FIG. 3D, a view of the tibial plateau mating surface 302of the implant 300 is illustrated. As is apparent from this view, thesurface is curved such that it is convex or substantially convex inorder to mate with the concave surface of the plateau. FIG. 3Eillustrates the upper surface 304 of the implant 300 furtherillustrating the use of three pegs 306 for anchoring the implant 300 tothe bone. As illustrated, the three pegs 306 are positioned to form atriangle. However, as will be appreciated by those of skill in the art,one or more pegs can be used, and the orientation of the pegs 306 to oneanother can be as shown, or any other suitable orientation that enablesthe desired anchoring. FIG. 3F illustrated a cross section of theimplant 300 taken along the lines F-F shown in FIG. 3E. Typically thepegs are oriented on the surface of the implant so that the peg isperpendicular to the femoral condyle, which may not result in the pegbeing perpendicular to the surface of the implant.

FIG. 3G illustrates the axial view of the femur 1000 having a lateralcondyle 1002 and a medial condyle 1004. The intercondylar fossa is alsoshown 1006 along with the lateral epicondyle 1008 and medial epicondyle1010. Also shown is the patellar surface of the femur 1012. The implant300 illustrated in FIG. 3A, is illustrated covering a portion of thelateral condyle. The pegs 306 are also shown that facilitate anchoringthe implant 300 to the condyle.

FIG. 3H illustrates a knee joint 1020 from an anterior perspective. Theimplant 300 is implanted over a condyle. As shown in FIG. 3I the implant300 is positioned such that it communicates with an implant 200 designedto correct a defect in the tibial plateau, such as those shown in FIG.2.

FIGS. 3J-K illustrate an implant 300 for placement on a condyle. In thisembodiment, at least one flat surface or chamfer cut 360 is provided tomate with a cut made on the surface of the condyle in preparing thejoint. The flat surface 360 typically does not encompass the entireproximal surface 304 of the implant 300.

FIG. 4A illustrates the design of a typical total knee arthroplasty(“TKA”) primary knee 499. Posterior cuts 498, anterior cuts 497 anddistal cuts 496 are provided as well as chamfer cuts 495.

FIGS. 4B and 4C illustrate another implant 400. As shown in FIG. 4B, theimplant 400 is configured such that it covers both the lateral andmedial femoral condyle along with the patellar surface of the femur1012. The implant 400 has a lateral condyle component 410 and a medialcondyle component 420 and a bridge 430 that connects the lateral condylecomponent 410 to the medial condyle component 420 while covering atleast a portion of the patellar surface of the femur 1012. The implant400 can optionally oppose one or more implants, such as those shown inFIG. 2, if desired. FIG. 4C is a side view of the implant of FIG. 4B. Asshown in FIG. 4C, the superior surface 402 of the implant 400 is curvedto correspond to the curvature of the femoral condyles. The curvaturecan be configured such that it corresponds to the actual curvature ofone or both of the existing femoral condyles, or to the curvature of oneor both of the femoral condyles after resurfacing of the joint. One ormore pegs 430 can be provided to assist in anchoring the implant to thebone. As will be appreciated by those of skill in the art, the implantcan be configured such that the superior surface contacting a firstcondyle is configured to male with the existing condule while a surfacecontacting a second condyle has one or more flat surfaces to mate with acondyle surface that has been modified.

FIG. 4D illustrates a top view of the implant 400 shown in FIG. 4B. Asis should be appreciated from this view, the inferior surface 404 of theimplant 400 is configured to conform to the shape of the femoralcondyles, e.g. the shape healthy femoral condyles would present to thetibial surface in a non-damaged joint.

FIGS. 4E and F illustrate perspective views of the implant from theinferior surface (i.e., tibial plateau mating surface).

FIG. 4G illustrates the axial view of the femur 1000 having a lateralcondyle 1002 and a medial condyle 1004. The intercondylar fossa is alsoshown 1006 along with the lateral epicondyle 1008. The implant 400illustrated in FIG. 4B, is illustrated covering both condyles and thepatellar surface of the femur 1012. The pegs 430 are also shown thatfacilitate anchoring the implant 400 to the condyle.

FIG. 4H illustrates a knee joint 1050 from an anterior perspective. Theimplant 400 is implanted over both condyles. As shown in FIG. 4I theimplant 400 is positioned such that it communicates with an implant 200designed to correct a defect in the tibial plateau, such as those shownin FIG. 2.

As will be appreciated by those of skill in the art, the implant 400 canbe manufactured from a material that has memory such that the implantcan be configured to snap-fit over the condyle. Alternatively, it can beshaped such that it conforms to the surface without the need of asnap-fit.

FIGS. 5A and 5B illustrate yet another implant 500 suitable forrepairing a damaged condyle. As shown in FIG. 5A, the implant 500 isconfigured such that it covers only one of the lateral or medial femoralcondyles 510. The implant differs from the implant of FIG. 3 in that theimplant 500 also covers at least a portion of the patellar surface ofthe femur 512.

Similar to the implant of FIG. 4, the implant can optionally oppose oneor more implants or opposing joint surfaces, such as those shown in FIG.2, and can be combined with other implants, such as the implants of FIG.3. FIG. 5C is a perspective side view of the implant of FIG. 5A. Asshown in FIG. 5C, the superior surface 502 of the implant 500 is curvedto correspond to the curvature of the femoral condyle that it mates withand the portion of the patellar surface of the femur that it covers. Oneor more pegs 530 can be provided to assist in anchoring the implant tothe bone. Additionally, an angled surface 503 can be provided on aninterior surface 502 of the condyle component that conforms to anoptionally provided cut made on the surface of the joint surface withwhich the implant mates.

FIG. 5D illustrates a perspective top view of the implant 500 shown inFIG. 5A. As is should be appreciated from this view, the inferiorsurface 504 of the implant 500 is configured to conform to the projectedshape of the femoral condyles, e.g. the shape healthy femoral condyleswould present to the tibial surface in a non-damaged joint.

FIG. 5E is a view of the implant 500 showing a hatched three pointloading support area which extends from a top portion 513 to a line(plane 17) and from a line (plane 18) to a bottom portion 515. Alsoillustrated are the pegs 530 extending from the superior surface. FIG.5F illustrates the superior surface of the implant 500 with the pegs 530extending from the superior surface. FIG. 5F also illustrates thehatched cantilever loading support area, which extends from the line(plane 18) to the top portion 513 of the implant. The loading forces anddirections for each support condition are based on physiological loadencounters. Table 1 shows the Physiological Loadings taken from a studyby Seth Greenwald.

TABLE 1 Set-up “1” “2” “3” Flexion Angle 0° 60° 90° (degree) NormalForce N 2,900 3,263 3,625 (lbs.) (652) (733.5) (815) Normal ForceWalking Stair Descent Stair Ascent Case (4.0 × BW^(*)) (4.5 × BW^(*))(5.0 × BW^(*)) ^(*)Body Weight (BW) taken as a 60 year old male, with173 cm height for an average body weight of 74 kg (163 lbs). ¹“TibialPlateau Surface Stress in TKA: A Factor Influencing Polymer FailureSeries III-Posterior Stabilized Designs;” Paul D. Postak, B.Sc.,Chrsitine S. Heim, B. Sc., A. Seth Greenwald, D. phil.; OthropedicResearch Labortories, The Mt. Sinai Medical Center, Cleveland, Ohio.Presented at the 62nd Annual AAOS Meeting 1995.

Using the implant 500 described in this application, the three pointloading will occur from set-up 1 (2900 N). To replicate a worst caseloading scenario, a 75/25 load distribution (75% of 2900 N=2175 N) willbe used. The loading will be concentrated on a 6 mm diameter circulararea located directly below and normal to the ped on the bearingsurface.

Turning to the cantilever loading shown in FIG. 5F, the loading willoccur from set-up 3, or 90°, at a 75/25 load distribution (75% of N=2719N). As with the above example, the loading will be concentrated on a 6mm diameter circular area located at the center of the posterior-mostportion of the medial condyle normal to the flat cut surface of theposterior condyle.

FIGS. 5G and H illustrate alternate embodiments of the implant 500having a rail design that provides one or more rails 521 along medialand/or lateral sides of the implant 500. The rail 521 can be positionedso that it extends along a portion of the medial 517 and/or lateral 519sides before communicating with the angled surface 503. As will beappreciate, a single side rail 521 can be provided without departingfrom the scope of the invention.

FIG. 5I illustrates another embodiment of an implant 500 having a keeldesign. A keel 523 (or centrally formed rail) is provided on thesuperior surface of the implant. In this embodiment, the keel 523 islocated on the surface of the implant, but not at the sides. As will beappreciated, the keel can be centered, as shown, substantially centered,or located off-center. An angled surface 503 can be provided tocommunicate with a modified joint surface. Alternatively, where thejoint surface is worn or modified, the cut 503 could be configured tomate with the worn or modified surface.

FIG. 5J illustrates the axial view of the femur 1000 having a lateralcondyle 1002 and a medial condyle 1004. The intercondylar fossa is alsoshown 1006 along with the lateral epicondyle 1008 and the medialepicondyle 1010. The patellar surface of the femur 1012 is alsoillustrated. The implant 500, illustrated in FIG. 5A, is shown coveringthe lateral condyle and a portion of the patellar surface of the femur1012. The pegs 530 are also shown that facilitate anchoring the implant500 to the condyle and patellar surface.

FIG. 5K illustrates a knee joint 1020 from an anterior perspective. Theimplant 500 is implanted over the lateral condyle. FIG. 5L illustrates aknee joint 1020 with the implant 500 covering the medial condyle 1004.As illustrated in FIGS. 5K and L the shape of the implant 500corresponding to the patella surface can take on a variety of curvatureswithout departing from the scope of the invention.

Turning now to FIGS. 5M and N the implant 500 is positioned such that itcommunicates with an implant 200 designed to correct a defect in thetibial plateau, such as those shown in FIG. 2.

In another embodiment of the invention, the implant 500 can have asuperior surface 502 which substantially conforms to the surface of thecondyle but which has at one flat portion corresponding to an obliquecut on the bone as shown in FIG. 5O.

Turning now to FIG. 5P-Q an implant 500 is shown from a side view with a7° difference between the anterior and posterior cuts.

FIG. 5R-S illustrate an implant 500 having a contoured surface 560 formating with the joint surface and an anterior cut 561 and a posteriorcut 562. FIG. 55 shows the same implant 500 from a slightly differentangle. FIG. 5T illustrates another implant 500 having a contouredsurface 560 for mating with the joint surface and posterior cut 562, adistal cut 563, and a chamfer cut 564. In this embodiment no anteriorcut is provided. FIG. 5U illustrates the implant 500 of FIG. 5T from aside perspective. The cuts are typically less than the cut required fora TKA, i.e., typically less than 10 mm. The design of the cuts for thisimplant allow for a revision surgery to the knee, if required, at alater date.

FIGS. 6A-G illustrate the implant 500 of FIG. 5 with a graphicalrepresentation of the cross-sections 610, 620 from which a surface shapeof the implant is derived. FIG. 6A illustrates a top view of the implant500 sitting on top of the extracted surface shape 600. This view of theimplant 500 illustrates a notch 514 associated with the bridge sectionof the implant 512 which covers the patellar surface of the femur (orthe trochlea region) to provide a mating surface that approximates thecartilage surface. As will be appreciated by those of skill in the art,the shape of an implant designed for the medial condyle would notnecessarily be a mirror image of the implant designed for the lateralcondyle because of differences in anatomy. Thus, for example, the notch514 would not be present in an implant designed for the medial condyleand the patellar surface of the femur. Therefore, the implant can bedesigned to include all or part of the troclea region or to exclude itentirely.

FIG. 6B illustrates a bottom view of the implant 500 layered overanother derived surface shape 601. FIG. 6C is a bottom view showing theimplant 500 extending through the extracted surface shape 600 shown inFIG. 6A. FIG. 6D is a close-up view of the FIG. 6C showing the condylarwing of the implant covering the extracted surface 600. FIG. 6Eillustrates a top posterior view of the implant 500 positioned over thegraphical representation of the surface shape 600. FIG. 6F is ananterior view and FIG. 6G is a bottom-posterior view.

FIG. 7A-C illustrate an implant 700 for correcting a joint similar tothe implant 500 above. However, implant 700 consists of two components.The first component 710 engages a condyle of the femur, either medial orlateral depending on the design. The second component 720 engages thepatellar surface of the femur. As discussed with the previousembodiments, the surfaces of the implant 700 can be configured such thatthe distal surface 722 (e.g., the surface that faces the tibial plateau)is shaped based on a projection of the natural shape of the femurcompensating the design for valgus or varus deformities and/orflattening of the surface of the femur. Alternatively, the distalsurface can be shaped based on the shape of the tibial plateau toprovide a surface designed to optimally mate with the tibial plateau.The proximal surface 724 (e.g., the surface that engages the femoralcondyle) can be configured such that it mirrors the surface of the femurin either its damaged condition or its modified condition. Likewise, theproximal surface can have one or more flattened sections 726 that form,e.g., chamfer cuts. Additionally the surface can include mechanismsfacilitating attachment 728 to the femur, such as keels, teeth, cruciatestems, and the like. The medial facing portion of the condyle implanthas a tapered surface 730 while the lateral facing portion of thepatellar component also has a tapered surface such that each componentpresents tapered surfaces 730 to the other component.

By dividing the surfaces of the medial and lateral compartments intoindependent articulating surfaces, as shown in FIG. 7, the implantprovides improved fit of the conformal surfaces to the subchondral bone.Additionally, the lateral-anterior portion of the femur is shielded fromstress which could cause bone loss. Also, the smaller size of eachcomponent of the implant, enables the implant to be placed within thejoint using a smaller incision. Finally, the wear of the patellarcomponent is improved.

FIGS. 8A-F illustrate a patella 00 with an implants 810. The implant 810can have one or more pegs, cruciate stems, or other anchoringmechanisms, if desired. As will be appreciated by those of skill in theart, other designs can be arrived at using the teachings of thisdisclosure without departing from the scope of the invention. FIG. 8Aillustrates a perspective view of an intact patella 800. FIG. 8Billustrates the patella 800 wherein one surface of the patella 800 hasbeen cut for form a smooth surface 802 to mate with an implant. FIG. 8Cillustrates the patella 800 with an implant 810 positioned on the smoothsurface 802. The implant 810 has a plate structure 812 that abuts thesmooth surface of the patella 802 and a dome 814 positioned on the plate812 so that the dome is positioned in situ such that it will match thelocation of the patellar ridge. The implant 810 can be configured suchthat the edge of the plate is offset 1 mm from the actual edge of thepatella, as illustrated. As will be appreciated by those of skill in theart, the plate 812 and dome 814 can be formed as a single unit or formedfrom multiple components. FIG. 8D is a side view of the implant 810positioned on the patella 800. As shown, the dome is positioned on theimplant such that it is off-center. Optimal positioning of the dome willbe determined by the position of the patellar ridge.

Turning now to FIGS. 8E-F, the implant 810 is shown superimposed on theunaltered patella 800 in order to illustrate that the position of thedome 814 of the implant corresponds to the location of the patellarridge.

FIGS. 8G-J illustrate an alternative design for the patellar implant.FIG. 8G illustrates the implant 850 in its beginning stages as a blankwith a flat inferior surface 852 having pegs 854 extending therefrom foranchoring to the patella. The articular or superior surface 860 has arounded dome 856, and a round plate section 858 that can be machined tomatch the bone cut. The articular surface 860 takes on the appearance ofa “hat” or somberero, having a dome with a rim. The center of the dome856 is also the center of the bearing surface. The rim 858 is cut toconform to the needs of the particular patient. FIG. 8J illustrates animplant which has been formed from the blank shown in FIGS. 8G-I. FIG.8I shows a plurality of possible cut lines 862, 862′ for purposes ofillustration.

FIGS. 9A-C illustrate a lateral view of a knee 1020 having a combinationof the implants of implanted thereof. In FIG. 9A, an implant coveringthe condyle 900, is illustrated. Suitable implants can be, for example,those shown in FIGS. 3-8, as will be appreciated the portion of thecondyle covered anterior to posterior can include the entire weightbearing surface, a portion thereof, or a surface greater than the weightbearing surface. Thus, for example, the implant can be configured toterminate prior to the sulcus terminalis or after the sulcus terminalis(e.g., the groove on the femur that coincides with the area where loadbearing on the joint surface stops). As shown in FIGS. 9A-B, a patellarimplant 900 can also be provided. FIG. 9C illustrates a knee having acondyle implant 900, a patellar implant 800 and an implant for thetibial plateau 200.

FIGS. 10A-D provide an alternate view of the coronal plane of a kneejoint with one or more implants described above implanted therein. FIG.10A illustrates a knee having a tibial implant 200 placed therein. FIG.10B illustrates a knee with a condyle implant 300 placed therein. Asdescribed above, a plurality of the implants taught herein can beprovided within a joint in order to restore joint movement. FIG. 10Cillustrates a knee joint having two implants therein. First, a tibialimplant 200 is provided on the tibial plateau and a second implant 300is provided on the facing condyle. As will be appreciated by those ofskill in the art. The implants can be installed such that the implantspresent each other mating surfaces (as illustrated), or not. Forexample, where the tibial implant 200 is placed in the medialcompartment of the knee and the condyle implant 300 is placed in thelateral compartment. Other combinations will be appreciated by those ofskill in the art. Turning now to FIG. 10D, a tibial implant 200 isprovided along with a bicompartmental condyle implant 500. As discussedabove, these implants can be associated with the same compartment of theknee joint, but need not be.

The arthroplasty system can be designed to reflect aspects of the tibialshape, femoral shape and/or patellar shape. Tibial shape and femoralshape can include cartilage, bone or both. Moreover, the shape of theimplant can also include portions or all components of other articularstructures such as the menisci. The menisci are compressible, inparticular during gait or loading. For this reason, the implant can bedesigned to incorporate aspects of the meniscal shape accounting forcompression of the menisci during loading or physical activities. Forexample, the undersurface 204 of the implant 200 can be designed tomatch the shape of the tibial plateau including cartilage or bone orboth. The superior surface 202 of the implant 200 can be a composite ofthe articular surface of the tibia (in particular in areas that are notcovered by menisci) and the meniscus. Thus, the outer aspects of thedevice can be a reflection of meniscal height. Accounting forcompression, this can be, for example, 20%, 40%, 60% or 80% ofuncompressed meniscal height.

Similarly the superior surface 304 of the implant 300 can be designed tomatch the shape of the femoral condyle including cartilage or bone orboth. The inferior surface 302 of the implant 300 can be a composite ofthe surface of the tibial plateau (in particular in areas that are notcovered by menisci) and the meniscus. Thus, at least a portion of theouter aspects of the device can be a reflection of meniscal height.Accounting for compression, this can be, for example, 20%, 40%, 60% or80% of uncompressed meniscal height. These same properties can beapplied to the implants shown in FIGS. 4-8, as well.

In some embodiments, the outer aspect of the device reflecting themeniscal shape can be made of another, preferably compressible material.If a compressible material is selected it is preferably designed tosubstantially match the compressibility and biomechanical behavior ofthe meniscus. The entire device can be made of such a material ornon-metallic materials in general.

The height and shape of the menisci for any joint surface to be repairedcan be measured directly on an imaging test. If portions, or all, of themeniscus are torn, the meniscal height and shape can be derived frommeasurements of a contralateral joint or using measurements of otherarticular structures that can provide an estimate on meniscaldimensions.

In another embodiment, the superior face of the implants 300, 400 or 500can be shaped according to the femur. The shape can preferably bederived from the movement patterns of the femur relative to the tibialplateau thereby accounting for variations in femoral shape andtibiofemoral contact area as the femoral condyle flexes, extends,rotates, translates and glides on the tibia and menisci.

The movement patterns can be measured using any current or future testknow in the art such as fluoroscopy, MRI, gait analysis and combinationsthereof.

The arthroplasty can have two or more components, one essentially matingwith the tibial surface and the other substantially articulating withthe femoral component. The two components can have a flat opposingsurface. Alternatively, the opposing surface can be curved. Thecurvature can be a reflection of the tibial shape, the femoral shapeincluding during joint motion, and the meniscal shape and combinationsthereof.

Examples of single-component systems include, but are not limited to, aplastic, a polymer, a metal, a metal alloy, crystal free metals, abiologic material or combinations thereof. In certain embodiments, thesurface of the repair system facing the underlying bone can be smooth.In other embodiments, the surface of the repair system facing theunderlying bone can be porous or porous-coated. In another aspect, thesurface of the repair system facing the underlying bone is designed withone or more grooves, for example to facilitate the in-growth of thesurrounding tissue. The external surface of the device can have astep-like design, which can be advantageous for altering biomechanicalstresses. Optionally, flanges can also be added at one or more positionson the device (e.g., to prevent the repair system from rotating, tocontrol toggle and/or prevent settling into the marrow cavity). Theflanges can be part of a conical or a cylindrical design. A portion orall of the repair system facing the underlying bone can also be flatwhich can help to control depth of the implant and to prevent toggle.

Non-limiting examples of multiple-component systems include combinationsof metal, plastic, metal alloys, crystal free metals, and one or morebiological materials. One or more components of the articular surfacerepair system can be composed of a biologic material (e.g. a tissuescaffold with cells such as cartilage cells or stem cells alone orseeded within a substrate such as a bioresorable material or a tissuescaffold, allograft, autograft or combinations thereof) and/or anon-biological material (e.g., polyethylene or a chromium alloy such aschromium cobalt).

Thus, the repair system can include one or more areas of a singlematerial or a combination of materials, for example, the articularsurface repair system can have a first and a second component. The firstcomponent is typically designed to have size, thickness and curvaturesimilar to that of the cartilage tissue lost while the second componentis typically designed to have a curvature similar to the subchondralbone. In addition, the first component can have biomechanical propertiessimilar to articular cartilage, including but not limited to similarelasticity and resistance to axial loading or shear forces. The firstand the second component can consist of two different metals or metalalloys. One or more components of the system (e.g., the second portion)can be composed of a biologic material including, but not limited tobone, or a non-biologic material including, but not limited tohydroxyapatite, tantalum, a chromium alloy, chromium cobalt or othermetal alloys.

One or more regions of the articular surface repair system (e.g., theouter margin of the first portion and/or the second portion) can bebioresorbable, for example to allow the interface between the articularsurface repair system and the patient's normal cartilage, over time, tobe filled in with hyaline or fibrocartilage. Similarly, one or moreregions (e.g., the outer margin of the first portion of the articularsurface repair system and/or the second portion) can be porous. Thedegree of porosity can change throughout the porous region, linearly ornon-linearly, for where the degree of porosity will typically decreasetowards the center of the articular surface repair system. The pores canbe designed for in-growth of cartilage cells, cartilage matrix, andconnective tissue thereby achieving a smooth interface between thearticular surface repair system and the surrounding cartilage.

The repair system (e.g., the second component in multiple componentsystems) can be attached to the patient's bone with use of a cement-likematerial such as methylmethacrylate, injectable hydroxy- orcalcium-apatite materials and the like.

In certain embodiments, one or more portions of the articular surfacerepair system can be pliable or liquid or deformable at the time ofimplantation and can harden later. Hardening can occur, for example,within 1 second to 2 hours (or any time period therebetween), preferablywith in 1 second to 30 minutes (or any time period therebetween), morepreferably between 1 second and 10 minutes (or any time periodtherebetween).

One or more components of the articular surface repair system can beadapted to receive injections. For example, the external surface of thearticular surface repair system can have one or more openings therein.The openings can be sized to receive screws, tubing, needles or otherdevices which can be inserted and advanced to the desired depth, forexample, through the articular surface repair system into the marrowspace. Injectables such as methylmethacrylate and injectable hydroxy- orcalcium-apatite materials can then be introduced through the opening (ortubing inserted therethrough) into the marrow space thereby bonding thearticular surface repair system with the marrow space. Similarly, screwsor pins, or other anchoring mechanisms. can be inserted into theopenings and advanced to the underlying subchondral bone and the bonemarrow or epiphysis to achieve fixation of the articular surface repairsystem to the bone. Portions or all components of the screw or pin canbe bioresorbable, for example, the distal portion of a screw thatprotrudes into the marrow space can be bioresorbable. During the initialperiod after the surgery, the screw can provide the primary fixation ofthe articular surface repair system. Subsequently, ingrowth of bone intoa porous coated area along the undersurface of the articular cartilagerepair system can take over as the primary stabilizer of the articularsurface repair system against the bone.

The articular surface repair system can be anchored to the patient'sbone with use of a pin or screw or other attachment mechanism. Theattachment mechanism can be bioresorbable. The screw or pin orattachment mechanism can be inserted and advanced towards the articularsurface repair system from a non-cartilage covered portion of the boneor from a non-weight-bearing surface of the joint.

The interface between the articular surface repair system and thesurrounding normal cartilage can be at an angle, for example oriented atan angle of 90 degrees relative to the underlying subchondral bone.Suitable angles can be determined in view of the teachings herein, andin certain cases, non-90 degree angles can have advantages with regardto load distribution along the interface between the articular surfacerepair system and the surrounding normal cartilage.

The interface between the articular surface repair system and thesurrounding normal cartilage and/or bone can be covered with apharmaceutical or bioactive agent, for example a material thatstimulates the biological integration of the repair system into thenormal cartilage and/or bone. The surface area of the interface can beirregular, for example, to increase exposure of the interface topharmaceutical or bioactive agents.

E. Pre-Existing Repair Systems

As described herein, repair systems of various sizes, curvatures andthicknesses can be obtained. These repair systems can be catalogued andstored to create a library of systems from which an appropriate systemfor an individual patient can then be selected. In other words, adefect, or an articular surface, is assessed in a particular subject anda pre-existing repair system having a suitable shape and size isselected from the library for further manipulation (e.g., shaping) andimplantation.

F. Mini-Prosthesis

As noted above, the methods and compositions described herein can beused to replace only a portion of the articular surface, for example, anarea of diseased cartilage or lost cartilage on the articular surface.In these systems, the articular surface repair system can be designed toreplace only the area of diseased or lost cartilage or it can extendbeyond the area of diseased or lost cartilage, e.g., 3 or 5 mm intonormal adjacent cartilage. In certain embodiments, the prosthesisreplaces less than about 70% to 80% (or any value therebetween) of thearticular surface (e.g., any given articular surface such as a singlefemoral condyle, etc.), preferably, less than about 50% to 70% (or anyvalue therebetween), more preferably, less than about 30% to 50% (or anyvalue therebetween), more preferably less than about 20% to 30% (or anyvalue therebetween), even more preferably less than about 20% of thearticular surface.

The prosthesis can include multiple components, for example a componentthat is implanted into the bone (e.g., a metallic device) attached to acomponent that is shaped to cover the defect of the cartilage overlayingthe bone. Additional components, for example intermediate plates,meniscal repair systems and the like can also be included. It iscontemplated that each component replaces less than all of thecorresponding articular surface. However, each component need notreplace the same portion of the articular surface. In other words, theprosthesis can have a bone-implanted component that replaces less than30% of the bone and a cartilage component that replaces 60% of thecartilage. The prosthesis can include any combination, provided eachcomponent replaces less than the entire articular surface.

The articular surface repair system can be formed or selected so that itwill achieve a near anatomic fit or match with the surrounding oradjacent cartilage or bone. Typically, the articular surface repairsystem is formed and/or selected so that its outer margin located at theexternal surface will be aligned with the surrounding or adjacentcartilage.

Thus, the articular repair system can be designed to replace theweight-bearing portion (or more or less than the weight bearing portion)of an articular surface, for example in a femoral condyle. Theweight-bearing surface refers to the contact area between two opposingarticular surfaces during activities of normal daily living (e.g.,normal gait). At least one or more weight-bearing portions can bereplaced in this manner, e.g., on a femoral condyle and on a tibia.

In other embodiments, an area of diseased cartilage or cartilage losscan be identified in a weight-bearing area and only a portion of theweight-bearing area, specifically the portion containing the diseasedcartilage or area of cartilage loss, can be replaced with an articularsurface repair system.

In another embodiment, the articular repair system can be designed orselected to replace substantially all of the articular surface, e.g. acondyle.

In another embodiment, for example, in patients with diffuse cartilageloss, the articular repair system can be designed to replace an areaslightly larger than the weight-bearing surface.

In certain aspects, the defect to be repaired is located only on onearticular surface, typically the most diseased surface. For example, ina patient with severe cartilage loss in the medial femoral condyle butless severe disease in the tibia, the articular surface repair systemcan only be applied to the medial femoral condyle. Preferably, in anymethods described herein, the articular surface repair system isdesigned to achieve an exact or a near anatomic fit with the adjacentnormal cartilage.

In other embodiments, more than one articular surface can be repaired.The area(s) of repair will be typically limited to areas of diseasedcartilage or cartilage loss or areas slightly greater than the area ofdiseased cartilage or cartilage loss within the weight-bearingsurface(s).

In another embodiment, one or more components of the articular surfacerepair (e.g., the surface of the system that is pointing towards theunderlying bone or bone marrow) can be porous or porous coated. Avariety of different porous metal coatings have been proposed forenhancing fixation of a metallic prosthesis by bone tissue in-growth.Thus, for example, U.S. Pat. No. 3,855,638 to Pilliar issued Dec. 24,1974, discloses a surgical prosthetic device, which can be used as abone prosthesis, comprising a composite structure consisting of a solidmetallic material substrate and a porous coating of the same solidmetallic material adhered to and extending over at least a portion ofthe surface of the substrate. The porous coating consists of a pluralityof small discrete particles of metallic material bonded together attheir points of contact with each other to define a plurality ofconnected interstitial pores in the coating. The size and spacing of theparticles, which can be distributed in a plurality of monolayers, can besuch that the average interstitial pore size is not more than about 200microns. Additionally, the pore size distribution can be substantiallyuniform from the substrate-coating interface to the surface of thecoating. In another embodiment, the articular surface repair system cancontain one or more polymeric materials that can be loaded with andrelease therapeutic agents including drugs or other pharmacologicaltreatments that can be used for drug delivery. The polymeric materialscan, for example, be placed inside areas of porous coating. Thepolymeric materials can be used to release therapeutic drugs, e.g. boneor cartilage growth stimulating drugs. This embodiment can be combinedwith other embodiments, wherein portions of the articular surface repairsystem can be bioresorbable. For example, the first layer of anarticular surface repair system or portions of its first layer can bebioresorbable. As the first layer gets increasingly resorbed, localrelease of a cartilage growth-stimulating drug can facilitate in-growthof cartilage cells and matrix formation.

In any of the methods or compositions described herein, the articularsurface repair system can be pre-manufactured with a range of sizes,curvatures and thicknesses. Alternatively, the articular surface repairsystem can be custom-made for an individual patient.

IV. Manufacturing

A. Shaping

In certain instances shaping of the repair material will be requiredbefore or after formation (e.g., growth to desired thickness), forexample where the thickness of the required cartilage material is notuniform (e.g., where different sections of the cartilage replacement orregenerating material require different thicknesses).

The replacement material can be shaped by any suitable techniqueincluding, but not limited to, casting techniques, mechanical abrasion,laser abrasion or ablation, radiofrequency treatment, cryoablation,variations in exposure time and concentration of nutrients, enzymes orgrowth factors and any other means suitable for influencing or changingcartilage thickness. See, e.g., WO 00/15153 to Mansmann published Mar.23, 2000; If enzymatic digestion is used, certain sections of thecartilage replacement or regenerating material can be exposed to higherdoses of the enzyme or can be exposed longer as a means of achievingdifferent thicknesses and curvatures of the cartilage replacement orregenerating material in different sections of said material.

The material can be shaped manually and/or automatically, for exampleusing a device into which a pre-selected thickness and/or curvature hasbeen input and then programming the device using the input informationto achieve the desired shape.

In addition to, or instead of, shaping the cartilage repair material,the site of implantation (e.g., bone surface, any cartilage materialremaining, etc.) can also be shaped by any suitable technique in orderto enhance integration of the repair material.

B. Sizing

The articular repair system can be formed or selected so that it willachieve a near anatomic fit or match with the surrounding or adjacentcartilage, subchondral bone, menisci and/or other tissue. The shape ofthe repair system can be based on the analysis of an electronic image(e.g. MRI, CT, digital tomosynthesis, optical coherence tomography orthe like). If the articular repair system is intended to replace an areaof diseased cartilage or lost cartilage, the near anatomic fit can beachieved using a method that provides a virtual reconstruction of theshape of healthy cartilage in an electronic image.

In one embodiment of the invention, a near normal cartilage surface atthe position of the cartilage defect can be reconstructed byinterpolating the healthy cartilage surface across the cartilage defector area of diseased cartilage. This can, for example, be achieved bydescribing the healthy cartilage by means of a parametric surface (e.g.a B-spline surface), for which the control points are placed such thatthe parametric surface follows the contour of the healthy cartilage andbridges the cartilage defect or area of diseased cartilage. Thecontinuity properties of the parametric surface will provide a smoothintegration of the part that bridges the cartilage defect or area ofdiseased cartilage with the contour of the surrounding healthycartilage. The part of the parametric surface over the area of thecartilage defect or area of diseased cartilage can be used to determinethe shape or part of the shape of the articular repair system to matchwith the surrounding cartilage.

In another embodiment, a near normal cartilage surface at the positionof the cartilage defect or area of diseased cartilage can bereconstructed using morphological image processing. In a first step, thecartilage can be extracted from the electronic image using manual,semi-automated and/or automated segmentation techniques (e.g., manualtracing, region growing, live wire, model-based segmentation), resultingin a binary image. Defects in the cartilage appear as indentations thatcan be filled with a morphological closing operation performed in 2-D or3-D with an appropriately selected structuring element. The closingoperation is typically defined as a dilation followed by an erosion. Adilation operator sets the current pixel in the output image to 1 if atleast one pixel of the structuring element lies inside a region in thesource image. An erosion operator sets the current pixel in the outputimage to 1 if the whole structuring element lies inside a region in thesource image. The filling of the cartilage defect or area of diseasedcartilage creates a new surface over the area of the cartilage defect orarea of diseased cartilage that can be used to determine the shape orpart of the shape of the articular repair system to match with thesurrounding cartilage or subchondral bone.

As described above, the articular repair system can be formed orselected from a library or database of systems of various sizes,curvatures and thicknesses so that it will achieve a near anatomic fitor match with the surrounding or adjacent cartilage and/or subchondralbone. These systems can be pre-made or made to order for an individualpatient. In order to control the fit or match of the articular repairsystem with the surrounding or adjacent cartilage or subchondral bone ormenisci and other tissues preoperatively, a software program can be usedthat projects the articular repair system over the anatomic positionwhere it will be implanted. Suitable software is commercially availableand/or readily modified or designed by a skilled programmer.

In yet another embodiment, the articular surface repair system can beprojected over the implantation site using one or more 3-D images. Thecartilage and/or subchondral bone and other anatomic structures areextracted from a 3-D electronic image such as an MRI or a CT usingmanual, semi-automated and/or automated segmentation techniques. A 3-Drepresentation of the cartilage and/or subchondral bone and otheranatomic structures as well as the articular repair system is generated,for example using a polygon or NURBS surface or other parametric surfacerepresentation. For a description of various parametric surfacerepresentations see, for example Foley, J. D. et al., Computer Graphics:Principles and Practice in C; Addison-Wesley, 2^(nd) edition, 1995).

The 3-D representations of the cartilage and/or subchondral bone andother anatomic structures and the articular repair system can be mergedinto a common coordinate system. The articular repair system can then beplaced at the desired implantation site. The representations of thecartilage, subchondral bone, menisci and other anatomic structures andthe articular repair system are rendered into a 3-D image, for exampleapplication programming interfaces (APIs) OpenGL® (standard library ofadvanced 3-D graphics functions developed by SGI, Inc.; available aspart of the drivers for PC-based video cards, for example fromwww.nvidia.com for NVIDIA video cards or www.3dlabs.com for 3Dlabsproducts, or as part of the system software for Unix workstations) orDirectX® (multimedia API for Microsoft Windows® based PC systems;available from www.microsoft.com). The 3-D image can be rendered showingthe cartilage, subchondral bone, menisci or other anatomic objects, andthe articular repair system from varying angles, e.g. by rotating ormoving them interactively or non-interactively, in real-time ornon-real-time.

The software can be designed so that the articular repair system,including surgical tools and instruments with the best fit relative tothe cartilage and/or subchondral bone is automatically selected, forexample using some of the techniques described above. Alternatively, theoperator can select an articular repair system, including surgical toolsand instruments and project it or drag it onto the implantation siteusing suitable tools and techniques. The operator can move and rotatethe articular repair systems in three dimensions relative to theimplantation site and can perform a visual inspection of the fit betweenthe articular repair system and the implantation site. The visualinspection can be computer assisted. The procedure can be repeated untila satisfactory fit has been achieved. The procedure can be performedmanually by the operator; or it can be computer-assisted in whole orpart. For example, the software can select a first trial implant thatthe operator can test. The operator can evaluate the fit. The softwarecan be designed and used to highlight areas of poor alignment betweenthe implant and the surrounding cartilage or subchondral bone or meniscior other tissues. Based on this information, the software or theoperator can then select another implant and test its alignment. One ofskill in the art will readily be able to select, modify and/or createsuitable computer programs for the purposes described herein.

In another embodiment, the implantation site can be visualized using oneor more cross-sectional 2-D images. Typically, a series of 2-Dcross-sectional images will be used. The 2-D images can be generatedwith imaging tests such as CT, MRI, digital tomosynthesis, ultrasound,or optical coherence tomography using methods and tools known to thoseof skill in the art. The articular repair system can then besuperimposed onto one or more of these 2-D images. The 2-Dcross-sectional images can be reconstructed in other planes, e.g. fromsagittal to coronal, etc. Isotropic data sets (e.g., data sets where theslice thickness is the same or nearly the same as the in-planeresolution) or near isotropic data sets can also be used. Multipleplanes can be displayed simultaneously, for example using a split screendisplay. The operator can also scroll through the 2-D images in anydesired orientation in real time or near real time; the operator canrotate the imaged tissue volume while doing this. The articular repairsystem can be displayed in cross-section utilizing different displayplanes, e.g. sagittal, coronal or axial, typically matching those of the2-D images demonstrating the cartilage, subchondral bone, menisci orother tissue. Alternatively, a three-dimensional display can be used forthe articular repair system. The 2-D electronic image and the 2-D or 3-Drepresentation of the articular repair system can be merged into acommon coordinate system. The articular repair system can then be placedat the desired implantation site. The series of 2-D cross-sections ofthe anatomic structures, the implantation site and the articular repairsystem can be displayed interactively (e.g. the operator can scrollthrough a series of slices) or non-interactively (e.g. as an animationthat moves through the series of slices), in real-time or non-real-time.

C. Rapid Prototyping

Rapid prototyping is a technique for fabricating a three-dimensionalobject from a computer model of the object. A special printer is used tofabricate the prototype from a plurality of two-dimensional layers.Computer software sections the representations of the object into aplurality of distinct two-dimensional layers and then athree-dimensional printer fabricates a layer of material for each layersectioned by the software. Together the various fabricated layers formthe desired prototype. More information about rapid prototypingtechniques is available in US Patent Publication No 2002/0079601A1 toRussell et al., published Jun. 27, 2002. An advantage to using rapidprototyping is that it enables the use of free form fabricationtechniques that use toxic or potent compounds safely. These compoundscan be safely incorporated in an excipient envelope, which reducesworker exposure

A powder piston and build bed are provided. Powder includes any material(metal, plastic, etc.) that can be made into a powder or bonded with aliquid. The power is rolled from a feeder source with a spreader onto asurface of a bed. The thickness of the layer is controlled by thecomputer. The print head then deposits a binder fluid onto the powderlayer at a location where it is desired that the powder bind. Powder isagain rolled into the build bed and the process is repeated, with thebinding fluid deposition being controlled at each layer to correspond tothe three-dimensional location of the device formation. For a furtherdiscussion of this process see, for example, US Patent Publication No2003/017365A1 to Monkhouse et al. published Sep. 18, 2003.

The rapid prototyping can use the two dimensional images obtained, asdescribed above in Section I, to determine each of the two-dimensionalshapes for each of the layers of the prototyping machine. In thisscenario, each two dimensional image slice would correspond to a twodimensional prototype slide. Alternatively, the three-dimensional shapeof the defect can be determined, as described above, and then brokendown into two dimensional slices for the rapid prototyping process. Theadvantage of using the three-dimensional model is that thetwo-dimensional slices used for the rapid prototyping machine can bealong the same plane as the two-dimensional images taken or along adifferent plane altogether.

Rapid prototyping can be combined or used in conjunction with castingtechniques. For example, a shell or container with inner dimensionscorresponding to an articular repair system can be made using rapidprototyping. Plastic or wax-like materials are typically used for thispurpose. The inside of the container can subsequently be coated, forexample with a ceramic, for subsequent casting. Using this process,personalized casts can be generated.

Rapid prototyping can be used for producing articular repair systems.Rapid prototyping can be performed at a manufacturing facility.Alternatively, it may be performed in the operating room after anintraoperative measurement has been performed.

V. Surgical Techniques

Prior to performing surgery on a patient, the surgeon can preoperativelymake a determination of the alignment of the knee using, for example, anerect AP x-ray. In performing preoperative assessment any lateral andpatella spurs that are present can be identified.

Using standard surgical techniques, the patient is anesthetized and anincision is made in order to provide access to the portion or portionsof the knee joint to be repaired. A medial portal can be used initiallyto enable arthroscopy of the joint. Thereafter, the medial portal can beincorporated into the operative incision and/or standard lateral portalscan be used.

Once an appropriate incision has been made, the exposed compartment isinspected for integrity, including the integrity of the ligamentstructures. If necessary, portions of the meniscus can be removed aswell as any spurs or osteophytes that were identified in the AP x-ray orthat may be present within the joint. In order to facilitate removal ofosteophytes, the surgeon may flex the knee to gain exposure toadditional medial and medial-posterior osteophytes. Additionally,osteophytes can be removed from the patella during this process. Ifnecessary, the medial and/or lateral meniscus can also be removed atthis point, if desired, along with the rim of the meniscus.

As would be appreciated by those of skill in the art, evaluation of themedial cruciate ligament may be required to facilitate tibial osteophyteremoval.

Once the joint surfaces have been prepared, the desired implants can beinserted into the joint.

A. Tibial Plateau

To insert the device 200 of FIG. 2 into the medial compartment, performa mini-incision arthrotomy medial to the patella tendon. Once theincision is made, expose the medial condyle and prepare a medial sleeveto about 1 cm below the joint line using a suitable knife and curvedosteotome. After preparing the medial sleeve, place a Z-retractor aroundthe medial tibial plateau and remove anterior portions of the meniscusand the osteophytes along the tibia and femur. At this point, the kneeshould be flexed to about 60° or more. Remove the Z-retractor and placethe implant against the most distal aspect of the femur and over thetibial plateau edge. Push the implant straight back. In some instances,application of valgus stress may ease insertion of the implant.

To insert the device of FIG. 2 into the lateral compartment, perform amini-incision arthrotomy lateral to the patella tendon. Once theincision is made, expose the lateral condyle and prepare a lateralsleeve to about 1 cm below the joint line using a suitable knife andcurved osteotome. After preparing the lateral sleeve, place aZ-retractor around the lateral tibial plateau and remove anteriorportions of the meniscus and the osteophytes along the tibia and femur.Remove the Z-retractor and place the implant against the distal aspectof the femur and over the tibial plateau edge. Hold the implant at a 45°angle and rotate the implant against the lateral condyle using a lateralto medial push toward the lateral spine. In some instances, applicationof varus stress may ease insertion of the implant.

Once any implant shown in FIG. 2 is implanted, the device should bepositioned within 0 to 2 mm of the AP boundaries of the tibial plateauand superimposed over the boundary. Verification of the range of motionshould then be performed to confirm that there is minimal translation ofthe implant. Once positioning is confirmed, closure of the wound isperformed using techniques known in the art.

As will be appreciated by those of skill in the art, additionaltreatment of the surface of the tibial plateau may be desirabledepending on the configuration of the implant 200. For example, one ormore channels or grooves may be formed on the surface of the tibialplateau to accommodate anchoring mechanisms such as the keel 212 shownin FIG. 2K or the translational movement cross-members 222, 221 shown inFIGS. 2M-N.

B. Condylar Repair Systems

To insert the device 300 shown in FIG. 3, depending on the condyle to berepaired either an antero-medial or antero-lateral skin incisions ismade which begins approximately 1 cm proximal to the superior border ofthe patella. The incision typically can range from, for example, 6-10 cmalong the edge of the patella. As will be appreciated by those of skillin the art, a longer incision may be required under some circumstances.

It may be required to excise excess deep synovium to improve access tothe joint. Additionally, all or part of the fat pad may also be excusedand to enable inspection of the opposite joint compartment.

Typically, osteophytes are removed from the entire medial and/or lateraledge of the femur and the tibia as well as any osteophytes on the edgeof the patella that might be significant.

Although it is possible, typically the devices 300 do not requireresection of the distal femur prior to implanting the device. However,if desired, bone cuts can be performed to provide a surface for theimplant.

At this juncture, the patient's leg is placed in 90° flexion position. Iguide can then be placed on the condyle which covers the distal femoralcartilage. The guide enables the surgeon to determine placement ofapertures that enable the implant 300 to be accurately placed on thecondyle. With the guide in place, holes are drilled into the condyle tocreate apertures from 1-3 mm in depth. Once the apertures have beencreated, the guide is removed and the implant 300 is installed on thesurface of the condyle. Cement can be used to facilitate adherence ofthe implant 300 to the condyle.

Where more than one condyle is to be repaired, e.g., using two implants300 of FIG. 3, or the implant 400 of FIG. 4, or where a condyle and aportion of the patellar surface is to be repaired, e.g., using theimplant 500 of FIG. 5, the surgical technique described herein would bemodified to, for example, provide a greater incision for accessing thejoint, provide additional apertures for receiving the pegs of theimplant, etc.

C. Patellar Repair System

To insert the device shown in FIG. 7, it may be appropriate to use theincisions made laterally or medially to the patella tendon and describedabove with respect to FIG. 2. First the patella is everted laterally andthe fat pad and synovium are bent back from around the periphery of thepatella. If desired, osteophytes can be removed. Prior to resurfacingthe natural patella 620, the knee should be manually taken throughseveral range of motion maneuvers to determine whether subluxation ispresent. If subluxation is present, then it may be necessary tomedialize the implant 600. The natural patella can then be cut in aplanar, or flat, manner such that a flat surface is presented to theimplant. The geometric center of the patella 620 is then typicallyaligned with the geometric center of the implant 600. In order to anchorthe implant 600 to the patella 620, one or more holes or apertures 612can be created in the patellar surface to accept the pegs 610 of theimplant 600.

VI. Kits

One or more of the implants described above can be combined together ina kit such that the surgeon can select one or more implants to be usedduring surgery.

The foregoing description of embodiments of the present invention hasbeen provided for the purposes of illustration and description. It isnot intended to be exhaustive or to limit the invention to the preciseforms disclosed. Many modifications and variations will be apparent tothe practitioner skilled in the art. The embodiments were chosen anddescribed in order to best explain the principles of the invention andits practical application, thereby enabling others skilled in the art tounderstand the invention and the various embodiments and with variousmodifications that are suited to the particular use contemplated. It isintended that the scope of the invention be defined by the followingclaims equivalents thereof.

1. A method of selecting an orthopedic implant for treating an articularsurface of a patient's joint using image data of the joint, the methodcomprising: deriving a shape of an articular surface of a joint fromimage data of the joint; selecting an articular implant from a libraryof implants based on at least one dimension from the derived shape ofthe articular surface; altering the selected articular implant toprovide a patient specific implant.
 2. The method of claim 1, whereinthe step of altering the articular implant includes altering one or moreof a dimension, feature, curvature, and surface of the articularimplant.
 3. The method of claim 1, wherein the step of selecting furtherincludes the step of selecting at least one of a length, width, height,curvature, thickness, contour and shape of the articular implant fromthe derived shape.
 4. The method of claim 1, further comprisingdesigning an instrument for use in implanting the selected articularimplant, wherein at least a portion of the instrument is based on thederived shape.
 5. The method of claim 1, further comprising designing aninstrument for use in implanting the selected articular implant, whereinat least a portion of the instrument is based on the determineddimensions of the joint.
 6. The method of claim 1, further comprisingdetermining an axis associated with the joint.
 7. The method of claim 6,wherein the articular implant is selected based on the determined axis.8. The method of claim 6, further comprising altering the selectedimplant based on the determined axis.
 9. The method of claim 1, furthercomprising designing an instrument for use in implanting the selectedarticular implant, wherein at least a portion the instrument is based onthe determined axis.
 10. The method of claim 1, wherein the selectedimplant is an electronic model of an implant.
 11. The method of claim 1,wherein the selected implant is selected from a database of systems. 12.The method of claim 1, wherein the selected implant is a physicalimplant.
 13. The method of claim 1, further comprising: deriving a shapeof articular tissue associated with the articular surface, whereinselecting the articular implant is further based on the derived shape ofthe articular tissue.
 14. The method of claim 1, wherein the articularimplant is selected such that at least a portion of an outer surface ofthe implant corresponds to subchondral bone underlying cartilage. 15.The method of claim 14, wherein the cartilage is diseased.
 16. Themethod of claim 14, wherein the cartilage includes damaged and undamagedcartilage.
 17. The method of claim 1, wherein the articular implant isselected such that at least a portion an outer surface of the implantmatches an articular cartilage surface of the joint.
 18. The method ofclaim 1, wherein the image data is from the group of MRI, CT,ultrasound, laser, digital tomosynthesis, optical coherence tomography,optical imaging and combinations thereof.
 19. The method of claim 1,wherein the articular implant includes an inner bone-facing surfacehaving at least a portion that substantially matches the shape of anarticular surface of the patient's joint.
 20. The method of claim 1,further comprising producing the selected implant.
 21. The method ofclaim 1, wherein the articular implant is adapted for implantation at animplantation site located in one of a femoral condyle, a tibial plateau,a femoral head, an acetabulum, a shoulder, elbow, wrist, hand, ankle andfoot joint.
 22. A method of selecting an orthopedic implant for treatingan articular surface of a joint of a patient using a computer system,the method comprising: obtaining electronic image data of a joint of apatient; deriving a shape of bone of the joint from the image data;determining electronically from the derived shape one or more dimensionsassociated with an articular surface of the bone; selecting an articularimplant from a library of implants based on the one or more dimensionsassociated with the articular surface; and altering the articularimplant based on the one or more dimensions.
 23. The method of claim 22,wherein the step of altering the articular implant includes altering oneor more of a dimension, feature, curvature, and surface of the articularimplant.
 24. The method of claim 22, wherein the step of selectingfurther includes the step of selecting at least one of a length, width,height, thickness, contour and shape of the articular implant from thederived shape.
 25. The method of claim 22, further comprising designingan instrument for use in implanting the selected articular implant,wherein at least a portion of the instrument is based on the derivedshape.
 26. The method of claim 22, further comprising designing aninstrument for use in implanting the selected articular implant, whereinat least a portion of the instrument is based on the determineddimensions of the joint.
 27. The method of claim 22, further comprisingdetermining an axis associated with the joint.
 28. The method of claim27, wherein the articular implant is selected based on the determinedaxis.
 29. The method of claim 27, further comprising altering theselected implant based on the determined axis.
 30. The method of claim22, further comprising designing an instrument for use in implanting theselected articular implant, wherein at least a portion the instrument isbased on the determined axis.
 31. The method of claim 22, wherein theselected implant is an electronic model of an implant.
 32. The method ofclaim 22, wherein the selected implant is selected from a database ofsystems.
 33. The method of claim 22, wherein the selected implant is aphysical implant.
 34. The method of claim 22, further comprising:deriving a shape of articular tissue associated with the articularsurface, wherein selecting the articular implant is further based on thederived shape of the articular tissue.
 35. The method of claim 22,wherein the articular implant is selected such that at least a portionof an outer surface of the implant corresponds to subchondral boneunderlying cartilage.
 36. The method of claim 35, wherein the cartilageis diseased.
 37. The method of claim 35, wherein the cartilage includesdamaged and undamaged cartilage.
 38. The method of claim 22, wherein thearticular implant is selected such that at least a portion an outersurface of the implant matches an articular cartilage surface of thejoint.
 39. The method of claim 22, wherein the image data is from thegroup of MRI, CT, ultrasound, laser, digital tomosynthesis, opticalcoherence tomography, optical imaging and combinations thereof.
 40. Themethod of claim 22, wherein the articular implant includes an innerbone-facing surface having at least a portion that substantially matchesthe shape of an articular surface of the patient's joint.
 41. The methodof claim 22, further comprising producing the selected implant.
 42. Themethod of claim 22, wherein the articular implant is adapted forimplantation at an implantation site located in one of a femoralcondyle, a tibial plateau, a femoral head, an acetabulum, a shoulder,elbow, wrist, hand, ankle and foot joint.
 43. A method of selecting anarticular implant for treating an articular surface of a joint using acomputer system, the method comprising: obtaining electronic image dataof a joint of a patient; deriving a shape of a surface of cartilage ofthe joint from the image data; determining electronically from thederived shape one or more dimensions associated with an articularsurface of the joint; selecting an articular implant from a library ofimplants based on the one or more dimensions associated with thearticular surface; and altering the articular implant based on the oneor more dimensions.
 44. The method of claim 43, wherein the step ofselecting further includes the step of selecting at least one of alength, width, height, curvature, thickness, contour and shape of thearticular implant from the derived shape.
 45. The method of claim 43,wherein the step of altering the articular implant includes altering oneor more of a dimension, feature, and surface of the articular implant.46. A method of selecting an orthopedic implant for treating anarticular surface of a joint of a patient using a computer system, themethod comprising: obtaining electronic image data of a joint of apatient; deriving a shape of at least or portion of bone of the jointfrom the image data; selecting an articular implant from a library ofimplants based on the derived shape; and altering the articular implantbased on the derived shape.
 47. A method of selecting an orthopedicimplant for treating an articular surface of a joint of a patient usinga computer system, the method comprising: obtaining electronic imagedata of a joint of a patient; deriving a shape of at least or portion ofcartilage of the joint from the image data; selecting an articularimplant from a library of implants based on the one or more dimensionsassociated with the articular surface; and altering the articularimplant based on the derived shape.